FDA Adverse Event
Malfunction
Summary report: N
530G INSULIN PUMP MMT-751NAP
MDR report key: 8049348
·
Received November 7, 2018
Report
- Report Number
- 2032227-2018-57226
- Event Type
- Malfunction
- Date Received
- November 7, 2018
- Date of Event
- April 3, 2018
- Report Date
- November 7, 2018
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OZO
- UDI-DI
- 00643169503700
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PUMP RECEIVED WITH DETACHED END CAP NOTED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS DAMAGED AND CUSTOMER EXPERIENCED THE HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE WAS 200, 241 MG/DL. THE CUSTOMER WAS TREATED VIA INSULIN PUMP. THE CUSTOMER REPORTED THE BACK OF THE INSULIN PUMP COMES OFF WHEN SHE WAS REWINDING AND BOTTOM OF THE INSULIN PUMP WAS DAMAGED. THE CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP WAS NORMAL. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WILL NEED TO BE REPLACED. ADVISE THE CUSTOMER TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO A BACKUP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 886056 | 530G INSULIN PUMP MMT-751NAP | ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND | OZO | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-751NAP | A4751NAPJ | 00643169503700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR |