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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 Wireless Communication Problem (3283)
Patient Problem Insufficient Information (4580)
Event Date 11/12/2021
Event Type  malfunction  
Manufacturer Narrative
Serial number: (b)(4), software version: n/a, color: grey, battery life remaining: n/a. Customer reports: inpen dose(s) are not transmitted to inpen app. Per visual inspection: no physical damage noted. The leadscrew was received halfway it's travel, the leadscrew was rewound properly. Leadscrew 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. Several attempts were made to pair inpen, every time app displayed dose doesn't match. The inpen does not pair with commercial mobile app. Inpen unable to send dose to inpen app due to communication / pairing anomaly. Inpen dose button was removed and electronic stack, flex connector and battery were inspected for electrical faults, moisture damage, workmanship and cracked or damage components. No visible anomaly was noted under the scope. However, lint and dust bunnies were found under dose button. A battery test was performed and battery measure at 3. 0 volts. Inpen was cut open and the flex connector was found to be corroded. It was determined that cause of inpen not pairing was cause by corrosion at the flex trace connector at the connection with encoder assembly. The customer complaint of no communication / pairing was confirmed.
 
Event Description
Information received by medtronic indicated that the inpen doses does not match. No harm requiring medical intervention was reported. The insulin pump 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 Key13101841
MDR Text Key285225686
Report Number3012822846-2021-00908
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-105NNGYNA
Device Catalogue NumberMMT-105NNGYNA
Device Lot NumberB0338
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/29/2021
Date Manufacturer Received12/14/2021
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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