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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COMPANION MEDICAL INC INPEN MMT-105ELPKNA ELI LILY PINK SYRINGE, PISTON

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COMPANION MEDICAL INC INPEN MMT-105ELPKNA ELI LILY PINK SYRINGE, PISTON Back to Search Results
Model Number MMT-105ELPKNA
Device Problems Break (1069); Failure to Align (2522)
Patient Problem Insufficient Information (4580)
Event Date 09/23/2021
Event Type  malfunction  
Manufacturer Narrative
Serial number: n/a, software version: n/a, color: pink, battery life remaining: n/a. The inpen screw retracts when dialing and advances when turning dose knob to the 0 mark and high resistance while dispensing due to dust/debris under the dose button, on washer, on the dose detent and dose knob. However, after attempting several times dispensing doses the debris got dislodged and inpen function properly. Inpen cap does not fit securely onto cartridge holder due to small snap cracked / broken. Test cap snaps securely to the returned cartridge holder.
 
Event Description
Information received by medtronic indicated that the insulin pen lid won't stay on and two of the numbers were no longer readable. No harm requiring medical intervention was reported. The device will be returned for analysis.
 
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Brand NameINPEN MMT-105ELPKNA ELI LILY 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 Key12616844
MDR Text Key278090533
Report Number3012822846-2021-00787
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
Reporter Occupation
Type of Report Initial
Report Date 10/12/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMMT-105ELPKNA
Device Catalogue NumberMMT-105ELPKNA
Device Lot NumberB93VV
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/05/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/08/2021
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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