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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COMPANION MEDICAL INC INPEN MMT-105NNPKNA NOVO NORDISK PINK SYRINGE, PISTON

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COMPANION MEDICAL INC INPEN MMT-105NNPKNA NOVO NORDISK PINK SYRINGE, PISTON Back to Search Results
Model Number MMT-105NNPKNA
Device Problems Break (1069); Failure to Align (2522)
Patient Problem Insufficient Information (4580)
Event Date 12/17/2021
Event Type  malfunction  
Event Description
Information received by medtronic indicated that insulin pen cap keep falling off. Customer reported that insulin pen was dropped. No harm requiring medical intervention was reported. Troubleshooting was not performed however, the customer will discontinue use of the device.
 
Manufacturer Narrative
Battery life remaining: < 4 weeks. Per visual inspection: cap does not fit securely to inpen. No physical damage to cartridge holder was noted. Dose window is missing. Customer reports: cap no longer stays attached. Unit paired successfully to commercial app. Inpen received with leadscrew fully re-wound. No drag was observed, the screw was not bent, advanced when dosage knob was pressed dialing a dosage and retracted appropriately. No resistance was observed when dosing without a cartridge installed. The screw advanced every time 30. 0u was dialed and dosed until the screw reached max extension. In conclusion: inpen cap does not fit securely onto cartridge holder due to small snap arm cracked / broken. The customer complaint of cap anomaly was confirmed.
 
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Brand NameINPEN MMT-105NNPKNA NOVO NORDISK PINK
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
COMPANION MEDICAL INC
1223 world trade drive, 100
san diego CA 92128
Manufacturer (Section G)
COMPANION MEDICAL INC
1223 world trade drive, 100
san diego CA 92128
Manufacturer Contact
tricha miles
1223 world trade drive, 100
san diego, CA 92128
7635140379
MDR Report Key13768370
MDR Text Key291709281
Report Number3012822846-2022-00233
Device Sequence Number1
Product Code FMF
UDI-Device Identifier000010862088000368
UDI-Public(01)000010862088000368(17)221106
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation
Type of Report Initial
Report Date 03/15/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/15/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMMT-105NNPKNA
Device Catalogue NumberMMT-105NNPKNA
Device Lot NumberB94BA
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/04/2022
Date Manufacturer Received03/09/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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