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U.S. Department of Health and Human Services

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

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COMPANION MEDICAL INC INPEN MMT-105ELBLNA ELI LILY BLUE SYRINGE, PISTON Back to Search Results
Model Number MMT-105ELBLNA
Device Problem Break (1069)
Patient Problem Insufficient Information (4580)
Event Date 08/01/2021
Event Type  malfunction  
Manufacturer Narrative
Serial number: n/a, software version: n/a , color: blue, battery life remaining: n/a. Customer reports: that her pen will not go past 4-5 units when turning the dial and when she tries to deliver that much no insulin comes out. Dial is broken and will not turn. Per visual inspection: cap does not fit securely to inpen. Several attempts were made to pair inpen, every time app displayed dose doesn't match and inpen not found. The inpen does not pair with commercial mobile app. The inpen screw retracts when dialing and advances when turning dose knob and high resistance while dispensing and dialing noted. The dose button was removed and no dust / debris under the dose button or dose knob noted. Inpen was cut open and after inspection it was found that the encoder pattern wheel tabs rotating and traveling off the keyed slots of dose nut guides. Encoder pattern wheel should never rotate. This causes an unexpected travel of the encoder pattern wheel creating resistance to dial and dispensing. Also contamination build up found caused by encoder wheel tabs rubbing at the walls of the dose nut. A battery test was performed, and battery measured 3. 0 volts. In conclusion: it was determined that pairing anomaly and the customer complaint of hard to turn the inpen, hard to dial, hard to push to give insulin was confirmed due to encoder pattern wheel rotating and traveling against the walls of the dose nut.
 
Event Description
Information received by medtronic indicated that the inpen did not go past 4-5 units when turning the dial. Customer stated that when they tried to deliver no insulin came out. No harm requiring medical intervention was reported. The product was returned for analysis.
 
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Brand NameINPEN MMT-105ELBLNA ELI LILY BLUE
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 Key13101957
MDR Text Key285226345
Report Number3012822846-2021-00917
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 12/28/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMMT-105ELBLNA
Device Catalogue NumberMMT-105ELBLNA
Device Lot NumberB93VT
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/07/2021
Date Manufacturer Received12/17/2021
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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