FDA Adverse Event
Malfunction
Summary report: N
530G INSULIN PUMP MMT-751NAH
MDR report key: 8662330
·
Received June 3, 2019
Report
- Report Number
- 2032227-2019-10657
- Event Type
- Malfunction
- Date Received
- June 3, 2019
- Date of Event
- May 29, 2019
- Report Date
- June 3, 2019
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OZO
- UDI-DI
- 00643169503687
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NM, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP HAD BUTTONS WERE HARD TO PRESS. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER STATES BATTERY LIFE DIMINISHED AND UNEXPLAINED NO DELIVERY ALERTS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 456765 | 530G INSULIN PUMP MMT-751NAH | ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND | OZO | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-751NAH | A4751NAHJ | 00643169503687 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 YR |