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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COMPANION MEDICAL INC INPEN
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COMPANION MEDICAL INC INPEN Back to Search Results
Model Number MMT-XXX
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Hyperglycemia (1905)
Event Date 11/13/2020
Event Type  malfunction  
Manufacturer Narrative
Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.
 
Event Description
The customer reported via phone call that the insulin pen had leadscrew anomaly.The customer stated the screw retracts when dialing the insulin dose.Customer¿s blood glucose was 140 mg/dl.No harm requiring medical intervention was reported.The insulin pen will be returned for analysis.
 
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Brand Name
INPEN
Type of Device
INPEN
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
neal grant
1223 world trade drive, 100
san diego, CA 92128
MDR Report Key10864800
MDR Text Key218983155
Report Number3012822846-2020-00105
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial
Report Date 11/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberMMT-XXX
Device Catalogue NumberMMT-XXX
Was Device Available for Evaluation? No
Date Manufacturer Received11/16/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age31 YR
Patient Weight73
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