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U.S. Department of Health and Human Services

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

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COMPANION MEDICAL INC INPEN MMT-105NNPKNA NOVO NORDISK PINK SYRINGE, PISTON Back to Search Results
Model Number MMT-105NNPKNA
Device Problems Computer Software Problem (1112); Patient Device Interaction Problem (4001)
Patient Problem Insufficient Information (4580)
Event Date 09/24/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Serial number: (b)(4), software version: 3. 8. 4, color: pink, battery life remaining: <2 months. Inpen received with resistance upon dispensing without a cartridge due to dust/debris under dose button, on washer, dose detent and dose knob. Unable to perform functional test due to high resistance at dose button. However, after attempting several times dispensing doses the debris got dislodged and inpen function properly. Unit paired successfully to commercial app. My inpen menu displayed: the following test values were dialed and dosed: 4. 0u, 4. 0u, 4. 0u, 4. 0u and 16. 0u. All values displayed accurately in the logbook. The alignment of the dose indicator mark and printed values on the dose knob is nominal. The patient complaint of dose log inaccuracies could not be confirmed. The screw was 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. No physical damage to injection foot or inpen was noted. 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
Information received by medtronic indicated that the insulin pen was broken or damaged. Customer stated that the insulin pen was unable to do 5 unit dose. No harm requiring medical intervention was reported. The insulin pen was returned for the analysis.
 
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Brand NameINPEN MMT-105NNPKNA NOVO NORDISK 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 Key12596714
MDR Text Key276843051
Report Number3012822846-2021-00785
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 10/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/13/2022
Device Model NumberMMT-105NNPKNA
Device Catalogue NumberMMT-105NNPKNA
Device Lot NumberB93LT
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/01/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/07/2021
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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