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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 Problem Obstruction of Flow (2423)
Patient Problem Insufficient Information (4580)
Event Date 11/15/2021
Event Type  malfunction  
Event Description
Information received by medtronic indicated that the insulin did not exit from inpen. No harm requiring medical intervention was reported. The insulin pen will be returned for analysis.
 
Manufacturer Narrative
(b)(4). Customer reports: inpen app is not recording the exact doses dialed on the inpen. Can't dial back past 4 units. Leadscrew pulling back into the inpen while dialing. Per visual inspection: no physical damage to injection foot or inpen was noted. The inpen screw retracts when dialing and advances when turning dose knob and high resistance while dispensing and dialing noted passed 4 units. The dose button was removed and no dust / debris under the dose button or dose knob noted. Unit paired successfully to commercial app with a small dose. My inpen menu displayed: the following test values were dialed and dosed: 3. 0u, 3. 0u, 3. 0u, 3. 0u and app recorded 1. 0u, 1. 5u, 2. 5u and 0. 5 u. Unable to completed functional test or dial any dose greater than 3. 0 due to lead screw anomaly. In conclusion; the customer complaint of lead screw anomaly, no able to dial more than 4 units and dose log anomaly were confirmed. Inpen will be further analyzed in (b)(6).
 
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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 Key13011306
MDR Text Key284114830
Report Number3012822846-2021-00873
Device Sequence Number1
Product Code FMF
UDI-Device Identifier000010862088000337
UDI-Public(01)000010862088000337(17)230222
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,Followup
Report Date 03/24/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/15/2021
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 NumberB94UT
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/02/2021
Is the Reporter a Health Professional? No
Date Manufacturer Received03/21/2022
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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