• 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-105NNBLNA NOVO NORDISK 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-105NNBLNA NOVO NORDISK BLUE SYRINGE, PISTON Back to Search Results
Model Number MMT-105NNBLNA
Device Problem Break (1069)
Patient Problem Insufficient Information (4580)
Event Date 06/04/2021
Event Type  malfunction  
Manufacturer Narrative
Serial number: (b)(4), software version: 3. 8. 5, color: blue , battery life remaining: <6 months. Customer reports: was trying to replace his insulin cartridge in the pen and broke the device. Per visual inspection: no cosmetic damage was noted. The inpen paired to the commercial app with small pairing dose. The screw is not bent. Leadscrew was received fully extended. Leadscrew was rewound. However, advances when turning dose knob to the 0 mark and high resistance while dispensing. Inpen dose button was removed and no lint or dust bunnies were found under dose button. Inpen was cut open and after inspection it was found that the encoder pattern wheel tabs rotating causing misalignment of the encoder and traveling off the keyed slots of dose nut guides. Encoder pattern wheel should never rotate. This causes an unexpected travel of the encoder pattern wheel creating resistance to dial and dispensing. In conclusion: a leadscrew anomaly was found during testing. The customer complaint of cosmetic / physical damage could not be confirmed.
 
Event Description
Information received by medtronic indicated that the insulin cartridge in the pen was broke. No harm requiring medical intervention was reported. The inpen will be returned for analysis.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameINPEN MMT-105NNBLNA NOVO NORDISK 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 Key13101866
MDR Text Key285222604
Report Number3012822846-2021-00911
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-105NNBLNA
Device Catalogue NumberMMT-105NNBLNA
Device Lot NumberB0031
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/02/2021
Date Manufacturer Received12/16/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/12/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-