Users of the FreeStyle Libre 3 sensors reported situations where they were receiving erroneously high glucose results. The inaccurate higher glucose values may lead to users calculating higher insulin bolus correctional doses based on inaccurate CGM glucose data. The inaccurate higher glucose values may also contribute to missed or delayed recognition of hypoglycemia, when the sensor incorrectly reports normal or even high glucose values when the actual glucose is trending low or is low. If the hypoglycemia missed by the device occurs acutely, a user may not be able to confirm the actual glucose with a self-monitored blood glucose (BG) and/or administer prompt intervention to raise glucose levels. The over-delivery of insulin and/or the missed or delayed detection of impending or overt hypoglycemia in the worst-case scenario may lead to severe hypoglycemia/hypoglycemic crisis with significant adverse health consequences. Such consequences include central nervous system dysfunction, loss of consciousness, seizure activity and may lead to coma, permanent neurological damage, and death.
Reason for recall: Users of the FreeStyle Libre 3 sensors reported situations where they were receiving erroneously high glucose results. The inaccurate higher glucose values may lead to users calculating higher insulin bolus correctional doses based on inaccurate CGM glucose data. The inaccurate higher glucose values may also contribute to missed or delayed recognition of hypoglycemia, when the sensor incorrectly reports normal or even high glucose values when the actual glucose is trending low or is low. If the hypoglycemia missed by the device occurs acutely, a user may not be able to confirm the actual glucose with a self-monitored blood glucose (BG) and/or administer prompt intervention to raise glucose levels. The over-delivery of insulin and/or the missed or delayed detection of impending or overt hypoglycemia in the worst-case scenario may lead to severe hypoglycemia/hypoglycemic crisis with significant adverse health consequences. Such consequences include central nervous system dysfunction, loss of consciousness, seizure activity and may lead to coma, permanent neurological damage, and death. Distribution: US distribution to states of: NJ, PA, OH, TX, VA, CA, NY, FL, WA, MS, MN, and WY Quantity: 8,174 Lot/code info: UDI-DI: 00357599818005. Lot/Serial Numbers: T60001948/0FP5Z6330 0FP5Z633C 0FP5Z90AF 0FP5Z90AL 0FP5Z90AR 0FP5Z90AX 0FP5Z90AZ 0FP5Z90C0 0FP5Z90C1 0FP5Z90C2 0FP5Z90C3 0FP5Z90C4 0FP5Z90C5 0FP5Z90C6 0FP5Z90C7 0FP5Z90C8 0FP5Z90CA 0FP5Z90CC 0FP5Z90CD 0FP5Z90CE 0FP5Z90CF 0FP5Z90J1 0FP5Z90J2 0FP5Z90J3 0FP5Z90J4 0FP5Z90J5 0FP5Z90J6 0FP5Z90J7 0FP5Z90J8 0FP5Z90J9 0FP5Z90JA 0FP5Z90JC 0FP5Z90JE 0FP5Z90JF 0FP5Z90JG 0FP5Z90JH 0FP5Z90JJ 0FP5Z90JK 0FP5Z90JM 0FP5Z90JN 0FP5Z90JR 0FP5Z90JT 0FP5Z90JU 0FP5Z90JX 0FP5Z90K0 0FP5Z90K2 0FP5Z90K3 0FP5Z90K4 0FP5Z90K5 0FP5Z90K6 0FP5Z90K7 0FP5Z90K8 0FP5Z90K9 0FP5Z90KC 0FP5Z90KD 0FP5Z90KE 0FP5Z90KF 0FP5Z90KG 0FP5Z90KH 0FP5Z90KJ 0FP5Z90KL 0FP5Z90KM 0FP5Z90KP 0FP5Z90KQ 0FP5Z90KR 0FP5Z90KT 0FP5Z90KU 0FP5Z90KV 0FP5Z90KW 0FP5Z90KY 0FP5Z90KZ 0FP5Z90L0 0FP5Z90L2 0FP5Z90L4 0FP5Z90L5 0FP5Z90L6 0FP5Z90L7 0FP5Z90L9 0FP5Z90LA 0FP5Z90LC 0FP5Z90LD 0FP5Z90T2 0FP5Z90T4 0FP5Z90T6 0FP5Z90T8 0FP5Z90T9 0FP5Z90TA 0FP5Z90TC 0FP5Z90TD 0FP5Z90TE 0FP5Z90TF 0FP5Z90TG 0FP5Z90TH 0FP5Z90TK 0FP5Z90TL 0FP5Z90TP 0FP5Z90TQ 0FP5Z90TR 0FP5Z90TT 0FP5Z90TU 0FP5Z90TW 0FP5Z90TX 0FP5Z90TY 0FP5Z90TZ 0FP5Z90U1 0FP5Z90U2 0FP5Z90U4 0FP5Z90U5 0FP5Z90U6 0FP5Z90U8 0FP5Z90UA 0FP5Z90UD 0FP5Z90UE 0FP5Z90UF 0FP5Z90UG 0FP5Z90UH 0FP5Z90UJ 0FP5Z90UK 0FP5Z90UL 0FP5Z90UM 0FP5Z90UN 0FP5Z90UP 0FP5Z90UQ 0FP5Z90UR 0FP5Z90UT 0FP5Z90UU 0FP5Z90UV 0FP5Z90UW 0FP5Z90UX 0FP5Z90UZ 0FP5Z90V0 0FP5Z90V1 0FP5Z90V2 0FP5Z90V3 0FP5Z90V4 0FP5Z90V5 0FP5Z90V6 0FP5Z90V7 0FP5Z90V8 0FP5Z90V9 0FP5Z90VA 0FP5Z90VC 0FP5Z9114 0FP5Z9115 0FP5Z9
00357599818005
Official record: FDA (Device enforcement) ↗
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