Telcare, LLC: Philips Connected Blood Glucose Meter, BGM 4; Model Number: TM0009;

Hazard

Telcare, LLC has received customer complaints related to battery expansion/swelling for its Philips Connected Blood Glucose Meter (i.e., BGM 4 brand name) Monitoring System.. The issue was identified by post market surveillance data (customer complaints) - events of battery expansion/swelling and associated symptoms, e.g., leading to the device's removable back cover (battery port) to separate. If there is a loss of primary function of the device due to the described device defect, an immediate health consequence that may result is prolonged hypoglycemia or hyperglycemia due to delay in treatment, as the blood glucose measurement is not available to guide treatment. In a worst-case situation, there is potential for battery swelling to result in explosion of the battery and/ or device. Exposure to explosion, and subsequently projectiles from the explosion, may result in several immediate health consequences, including concussion, headache, dizziness, eye irritation, blurred vision, eye injury, and vision impairment.

Details from the source

Reason for recall: Telcare, LLC has received customer complaints related to battery expansion/swelling for its Philips Connected Blood Glucose Meter (i.e., BGM 4 brand name) Monitoring System.. The issue was identified by post market surveillance data (customer complaints) - events of battery expansion/swelling and associated symptoms, e.g., leading to the device's removable back cover (battery port) to separate. If there is a loss of primary function of the device due to the described device defect, an immediate health consequence that may result is prolonged hypoglycemia or hyperglycemia due to delay in treatment, as the blood glucose measurement is not available to guide treatment. In a worst-case situation, there is potential for battery swelling to result in explosion of the battery and/ or device. Exposure to explosion, and subsequently projectiles from the explosion, may result in several immediate health consequences, including concussion, headache, dizziness, eye irritation, blurred vision, eye injury, and vision impairment. Distribution: US Nationwide distribution. Quantity: 34,764 units Lot/code info: Model Number: TM0009; UDI-DI: 00859519002407; Serial Numbers: Serial Numbers are formatted as TFXXXXXX or TGXXXXXX (X represents digits). Meter Serial Numbers: TF048802, TF098191, TF079123, TF076786, TF076836, TF089080, TF088984, TF086097, TF085390, TF085029, TF084238, TF098751, TF098975, TF098976, TF096704, TF096961, TF096966, TF117862, TF127077, TF049583, TF047153, TF063135, TF127267, TF100376, TF086287, TF104396, TF104399, TF104401, TF104403, TF104404, TF104405, TF104407, TF104408, TF104409, TF104410, TF104411, TF104412, TF104414, TF104415, TF104416, TF104417, TF104418, TF104421, TF104426, TF104427, TF104428, TF104429, TF104430, TF104431, TF104432, TF104433, TF104439, TF104440, TF104441, TF104442, TF104444, TF104446, TF104448, TF104449, TF104452, TF104453, TF104454, TF104455, TF104456, TF104458, TF104460, TF104461, TF104462, TF104467, TF104468, TF104469, TF104471, TF104473, TF104474, TF104479, TF104480, TF104481, TF104482, TF104483, TF104486, TF104487, TF104490, TF104491, TF104492, TF104494, TF104496, TF104498, TF104500, TF104501, TF104503, TF104505, TF104506, TF104510, TF104511, TF104512, TF104514, TF104516, TF104520, TF104521, TF104522, TF104525, TF104526, TF104527, TF104528, TF104529, TF104530, TF104534, TF104535, TF104537, TF104538, TF104541, TF104545, TF104554, TF104555, TF104566, TF104567, TF104568, TF104570, TF104571, TF104573, TF104576, TF104577, TF104579, TF104581, TF104585, TF104586, TF104588, TF104589, TF104590, TF104592, TF104593, TF104595, TF104599, TF104601,

UPC codes

00859519002407

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.