• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

COMPANION MEDICAL INC INPEN MMT-105ELBLNA ELI LILY BLUE SYRINGE, PISTON Back to Search Results
Model Number MMT-105ELBLNA
Device Problem Wireless Communication Problem (3283)
Patient Problem Insufficient Information (4580)
Event Date 09/06/2021
Event Type  malfunction  
Manufacturer Narrative
Serial number: n/a, software version: n/a, color: blue , battery life remaining: n/a. The inpen screw retracts when dialing and advances when turning dose knob to the 0 mark and resistance while dispensing due to dust/debris under the dose button, on washer, on the dose detent and dose knob. Unable to perform functional test or verify pairing / communication anomaly due to leadscrew anomaly. No physical damage to injection foot or inpen was noted.
 
Event Description
Information received by medtronic indicated that the insulin pen had dose log inaccuracy. Intended dose amount and dose amount recorded in the inpen app was not greater than 1. 0 unit. The difference between the dose intended and dose logged always 0. 5 units. No harm requiring medical intervention was reported. The device was returned for analysis.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key12528675
MDR Text Key274022165
Report Number3012822846-2021-00747
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 09/24/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/24/2021
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 NumberB94JU
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/13/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/22/2021
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

-
-