FDA Adverse Event
Malfunction
Summary report: N
530G INSULIN PUMP MMT-751LNAB
MDR report key: 8427132
·
Received March 16, 2019
Report
- Report Number
- 3004209178-2019-68547
- Event Type
- Malfunction
- Date Received
- March 16, 2019
- Date of Event
- March 11, 2019
- Report Date
- March 16, 2019
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OZO
- UDI-DI
- 00643169507746
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ME, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
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 MOTOR ERROR. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER STATES INSULIN PUMP GIVING ALARMS. CUSTOMER STATES INSULIN PUMP ALSO HAD NO DELIVERY ALARM AND REJECTED MEW BATTERY ALARM. CUSTOMER STATES SCREEN WAS HARD TO SEE IN BRIGHT SUNLIGHT AND RAINBOW EFFECTS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 220230 | 530G INSULIN PUMP MMT-751LNAB | ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND | OZO | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-751LNAB | A4751LNABJ | 00643169507746 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR |