Device product
InPen smart insulin pen, REF: MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA, MMT-105ELBLNA, MMT-105ELGYNA, MMT105ELPKNA
Z-1650-2025
Product summary
- Event
- Event 96421
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 8,986
- Official record key
device-enforcement:Z-1650-2025
Official wording
Reason: Insulin pens may have been incorrectly assembled therefore users could experience the following: either the insulin cartridge will not fit into the cartridge holder; or the cartridge holder may be difficult to remove from the insulin pen. If the issue is present, and if the user does not have backup insulin they may experience temporary hyperglycemia.
Code information: REF/UDI-DI(GTIN)/Lot: MMT-105NNBLNA/763000827182/D0020, D0034, D0036, D0038, D0045, D0046, D0050, D0057; MMT-105NNGYNA/763000827199/D0026, D0037, D0039, D0041, D0042, D0043, D0049; MMT-105NNPKNA/763000827205/D0029, D0030, D0040, D0051, D0062; MMT-105ELBLNA/763000827151/D0021, D0033, D0035, D0044, D0059, D0060, D0061; MMT-105ELGYNA/763000827168/D0031, D0032, D0047, D0068; MMT105ELPKNA/763000827175/D0027, D0028, D0048
Distribution pattern: US: OK, IA, NC, SC, MI, MN, CA, AZ, AL, MO, WA, IL, KS, TX, FL, MT, MD, OH, VA, NY, TN, HI, MA, NJ, PA, CO, WI, GA, CT, NE, OR, LA, NM, SD, ND, IN, NV, WV, RI, AR, NH
Derived failure modes
-
Unknown
Insulin pens may have been incorrectly assembled therefore users could experience the following: either the insulin cartridge will not fit into the cartridge holder; or the cartridge holder may be difficult to remove from the insulin pen. If the issue is present, and if the user does not have backup insulin they may experience temporary hyperglycemia.