INPEN MMT-105NNPKNA NOVO NORDISK PINK
Report
- Report Number
- 3012822846-2024-00097
- Event Type
- Injury
- Date Received
- January 29, 2024
- Date of Event
- January 4, 2024
- Report Date
- April 16, 2024
- Manufacturer
- COMPANION MEDICAL INC
- Product Code
- FMF
- UDI-DI
- 000010862088000368
- PMA / PMN Number
- K201337
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- 003
Narratives
PER VISUAL INSPECTION: NO PHYSICAL DAMAGE TO CARTRIDGE HOLDER. FRONT SHELL DOES NOT FIT SECURELY TO INPEN. INPEN DID NOT PAIR WITH COMMERCIAL APP. HOWEVER, INPEN DID TRANSMIT TO MANUFACTURING APP. PERFORMED ENCODER BOND INVESTIGATION AND FOUND THAT THE ENCODER PATTERN WHEEL TABS ROTATING 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. ALSO, PLASTIC SHAVINGS CONTAMINATION BUILDS UP FOUND CAUSED BY ENCODER WHEEL TABS RUBBING AT THE WALLS OF THE DOSE NUT. ABRASIONS DOWN THE LENGTH OF THE DOSE NUT. UNABLE TO PERFORM BASELINE/WIRELESS FUNCTIONALITY AND DISPLACEMENT DOSE ACCURACY TEST. PERFORMED LEADSCREW RESET TORQUE TEST. INPEN PASSED AND IS WITHIN SPECIFICATION (CCW: 3.85OZF-IN) .INPEN FAILED FRONT CAP INVESTIGATION. INPEN FRONT SHELL DOES NOT FIT SECURELY ONTO CARTRIDGE HOLDER DUE TO SMALL SNAP ARM BEING CRACKED / BROKEN. UNABLE TO CONFIRM PHONE APP NOT RECORDING EXACT DOSES DUE TO INPEN DID NOT COMMUNICATE WITH COMMERCIAL APP SUCCESSFULLY, THEREFORE UNABLE TO CONFIRM EXACT DOSES DIAL NOT RECORDING DUE TO ENCODER PATTERN WHEEL TABS ROTATING AND TRAVELING OFF THE KEYED SLOTS OF DOSE NUT GUIDES. IN CONCLUSION: IT WAS DETERMINED FROM DESTRUCTIVE ANALYSIS THAT THE DIFFICULT TO DIAL/DOSE WAS CAUSED BY A PATTERN WHEEL MISALIGNMENT DUE TO AN ENCODER BASE BOND FAILURE. THIS CAN AFFECT INSULIN DELIVERY. THEREFORE, THE CUSTOMER CONCERN OF DOSE DIAL BEING DIFFICULT TO DIAL/DOSE WAS CONFIRMED. UNABLE TO CONFIRM EXACT DOSES DIAL NOT RECORDING DUE TO ENCODER PATTERN WHEEL TABS ROTATING AND TRAVELING OFF THE KEYED SLOTS OF DOSE NUT GUIDE MAKING IT DIFFICULT TO DIAL. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.
PER VISUAL INSPECTION: NO PHYSICAL DAMAGE TO CARTRIDGE HOLDER. FRONT SHELL DOES NOT FIT SECURELY TO INPEN. INPEN DID NOT PAIR WITH COMMERCIAL APP. HOWEVER, INPEN DID TRANSMIT TO MANUFACTURING APP. PERFORMED ENCODER BOND INVESTIGATION AND FOUND THAT THE ENCODER PATTERN WHEEL TABS ROTATING 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. ALSO, PLASTIC SHAVINGS CONTAMINATION BUILDS UP FOUND CAUSED BY ENCODER WHEEL TABS RUBBING AT THE WALLS OF THE DOSE NUT. ABRASIONS DOWN THE LENGTH OF THE DOSE NUT. UNABLE TO PERFORM BASELINE/WIRELESS FUNCTIONALITY AND DISPLACEMENT DOSE ACCURACY TEST. PERFORMED LEADSCREW RESET TORQUE TEST. INPEN PASSED AND IS WITHIN SPECIFICATION (CCW: 3.85OZF-IN) .INPEN FAILED FRONT CAP INVESTIGATION. INPEN FRONT SHELL DOES NOT FIT SECURELY ONTO CARTRIDGE HOLDER DUE TO SMALL SNAP ARM BEING CRACKED / BROKEN. UNABLE TO CONFIRM PHONE APP NOT RECORDING EXACT DOSES DUE TO INPEN DID NOT COMMUNICATE WITH COMMERCIAL APP SUCCESSFULLY, THEREFORE UNABLE TO CONFIRM EXACT DOSES DIAL NOT RECORDING DUE TO ENCODER PATTERN WHEEL TABS ROTATING AND TRAVELING OFF THE KEYED SLOTS OF DOSE NUT GUIDES. IN CONCLUSION: IT WAS DETERMINED FROM DESTRUCTIVE ANALYSIS THAT THE DIFFICULT TO DIAL/DOSE WAS CAUSED BY A PATTERN WHEEL MISALIGNMENT DUE TO AN ENCODER BASE BOND FAILURE. THIS CAN AFFECT INSULIN DELIVERY. THEREFORE, THE CUSTOMER CONCERN OF DOSE DIAL BEING DIFFICULT TO DIAL/DOSE WAS CONFIRMED. UNABLE TO CONFIRM EXACT DOSES DIAL NOT RECORDING DUE TO ENCODER PATTERN WHEEL TABS ROTATING AND TRAVELING OFF THE KEYED SLOTS OF DOSE NUT GUIDE MAKING IT DIFFICULT TO DIAL. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
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. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER EXPERIENCED HYPERGLYCEMIA WITH A BLOOD GLUCOSE VALUE OF 379 MG/DL. THE CUSTOMER REPORTED INPEN APP WAS NOT RECORDING THE EXACT DOSES DIALED ON THE INPEN TROUBLESHOOTING WAS PERFORMED. IT WAS FOUND THAT THE CUSTOMER HAS TREATED THE HIGH BLOOD GLUCOSE EVENT WITH THE MANUAL INJECTION, INTRAVENOUS DRIP AND EMERGENCY MEDICAL SERVICES. IT WAS UNKNOWN IF THE CUSTOMER WAS USING THE PUMP WITHIN 48 HOURS OF THE REPORTED EVENT. IT WAS UNKNOWN IF THE AUTO-MODE FEATURE WAS ACTIVE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE CUSTOMER WILL DISCONTINUE THE USE OF THE DEVICE AND WILL BE RETURNED FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1393490 | INPEN MMT-105NNPKNA NOVO NORDISK PINK | SYRINGE, PISTON | FMF | COMPANION MEDICAL INC | MMT-105NNPKNA | B0592 | 000010862088000368 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Female | Required Intervention |