FDA Adverse Event
Malfunction
Summary report: N
PUMP MMT-1715KM 630G 3ML BLACK MEDI
MDR report key: 12216232
·
Received July 23, 2021
Report
- Report Number
- 2032227-2021-171422
- Event Type
- Malfunction
- Date Received
- July 23, 2021
- Date of Event
- June 9, 2021
- Report Date
- July 23, 2021
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OZO
- UDI-DI
- 000000643169873834
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
UNIT PASSED DISPLACEMENT AND SELF TESTS. NO UNEXPECTED THE CRITICAL BLOCK AND INVERSE CRITICAL BLOCK DID NOT ADD TO ZERO, 4 ALARMS NOTED DURING TESTING. HOWEVER, THE CRITICAL BLOCK AND INVERSE CRITICAL BLOCK DID NOT ADD TO ZERO ALARM, LINE NUMBER 213 FILE NUMBER 30, IS FOUND IN THE FORMATTED HISTORY FILE DUE TO A SOFTWARE ERROR. (B)(4).
Description of Event or Problem · 1
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD MULTIPLE PUMP ERROR ALARM. CUSTOMER WAS ABLE TO SUCCESSFUL THE ALARM. CUSTOMER WAS ABLE TO COMPLETE REWIND. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE DEVICE WILL BE RETURNED FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1118174 | PUMP MMT-1715KM 630G 3ML BLACK MEDI | ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND | OZO | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-1715KM | HG2GCH0 | 000000643169873834 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR |