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U.S. Department of Health and Human Services

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

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COMPANION MEDICAL INC INPEN MMT-105NNGYNA NOVO NORDISK GRAY SYRINGE, PISTON Back to Search Results
Model Number MMT-105NNGYNA
Device Problem Unintended Movement (3026)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/03/2021
Event Type  malfunction  
Manufacturer Narrative
Unit paired successfully to commercial mobile app. Inpen high resistance was felt upon dispensing without a cartridge due to dust/debris under dose button, on washer and dose detent. My inpen menu displayed: the following test values were dialed and dosed: 4. 0u, 4. 0u, 4. 0u, 4. 0u this values displayed accurately in the logbook. However, two 16 units values were dialed and 12. 0 u and 9. 5 u were recorded. The inpen values of 16 units transmitted did not matched bolus dialed, problem was isolated to the high resistance cause by dust/debris under dose button, on washer and dose detent. Inpen received with missing dose window. The alignment of the dose indicator mark and printed values on the dose knob is nominal. No misalignment of the dial was noted.
 
Event Description
The customer's family member reported via phone call that the insulin pen dose knob is misaligned with the dose mark indicator. Customer¿s blood glucose was unknown. No harm requiring medical intervention was reported. The insulin pen was returned for analysis.
 
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Brand NameINPEN MMT-105NNGYNA NOVO NORDISK GRAY
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 Key11940799
MDR Text Key258016347
Report Number3012822846-2021-00500
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation
Type of Report Initial
Report Date 06/04/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMMT-105NNGYNA
Device Catalogue NumberMMT-105NNGYNA
Device Lot NumberB93EP
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/02/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/04/2021
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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