Medtronic MiniMed, Inc.: MiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 With Software 6.60 and 6.61

Hazard

Three software defects (Pump Error 53, BG check, and Critical Pump Error (Open Book Image)) that occurred as a result of software updates (versions 6.60, 6.61, and 6.62), which could result in a risk of hypoglycemia or hyperglycemia due to inaccuracies in insulin delivery (either under-delivery, over-delivery, or cessation of delivery).

Details from the source

Reason for recall: Three software defects (Pump Error 53, BG check, and Critical Pump Error (Open Book Image)) that occurred as a result of software updates (versions 6.60, 6.61, and 6.62), which could result in a risk of hypoglycemia or hyperglycemia due to inaccuracies in insulin delivery (either under-delivery, over-delivery, or cessation of delivery). Distribution: Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH,NJ, NM, NV, NY, OH,OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the country of Israel. Quantity: 26,851 pumps Lot/code info: MiniMed 780G Model Number: MMT-1884 UDI-DI code: 763000414344 Serial Numbers: NG2445689H NG2445778H NG2455039H NG2461527H NG2461608H NG2471389H NG2471573H NG2472820H NG2473989H NG2480622H NG2481237H NG2488091H NG2489139H NG2489358H NG2493893H NG2494899H NG2496212H NG2496474H NG2497261H NG2499391H NG2499496H NG2500475H NG2500548H NG2501835H NG2502145H NG2502898H NG2507769H NG2507907H NG2508301H NG2508631H NG2508977H NG2511996H NG2513292H NG2521020H NG2522070H NG2523184H NG2530419H NG2531373H NG2531462H NG2531531H NG2532792H NG2533855H NG2535235H NG2535576H NG2537531H NG2538456H NG2540108H NG2541102H NG2541837H NG2543029H NG2544725H NG2548997H NG2550437H NG2570180H NG2570258H NG2570863H NG2576778H NG2579113H NG2579956H NG2580323H NG2580479H NG2583059H NG2583537H NG2586717H NG2589082H NG2590426H NG2603812H NG2603854H NG2604027H NG2611960H NG2612797H NG2614177H NG2617670H NG2617983H NG2629660H NG2635544H NG2636572H NG2637401H NG2642169H NG2644227H NG2644567H NG2647406H NG2647913H NG2648318H NG2649298H NG2656257H NG2656473H NG2657321H NG2657360H NG2658332H NG2659390H NG2659574H NG2697897H NG2697936H NG2698209H NG2698900H NG2705266H NG2706152H NG2710968H NG2712109H NG2714386H NG2718094H NG2723617H NG2724376H NG2724445H NG2742517H NG2742729H NG2742925H NG2742927H NG2745927H NG2748918H NG2748985H NG2749113H NG2749121H NG2749143H NG2750007H NG2750299H NG2751081H NG2751191H NG2752539H NG2752574H NG2753164H NG2753234H NG2753931H NG2754038H NG2760759H NG2760871H NG2761027H NG2761050H NG2

UPC codes

763000414344, 763000439859, 763000545604, 763000640095, 763000758547

Source

Official record: FDA (Device enforcement) ↗

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