FDA Adverse Event
Malfunction
Summary report: N
530G INSULIN PUMP MMT-751NAL
MDR report key: 9249484
·
Received October 29, 2019
Report
- Report Number
- 2032227-2019-110605
- Event Type
- Malfunction
- Date Received
- October 29, 2019
- Date of Event
- July 23, 2017
- Report Date
- October 29, 2019
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OZO
- UDI-DI
- 00643169503694
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). INSULIN PUMP WAS RECEIVED WITH NO BUTTON RESPONSE DUE TO UNLOCKED LCD KEYPAD CONNECTOR. UNABLE TO VERIFY LOST SENSOR ALARM AND PERFORM ALL FUNCTIONAL TESTS, INCLUDING THE IDLE CURRENT MEASUREMENT TEST, RUN CURRENT MEASUREMENT TEST, SELF TEST, OFF NO POWER TEST, UNEXPECTED RESTART ERROR TEST, DISPLACEMENT TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME, COMPROMISED FORCE SENSOR SYSTEM TEST, REWIND TEST AND EXCESSIVE NO DELIVERY TEST DUE TO NO BUTTON RESPONSE.
Description of Event or Problem · 1
CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS NOT COMMUNICATING WITH THE TRANSMITTER. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1043086 | 530G INSULIN PUMP MMT-751NAL | ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND | OZO | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-751NAL | A4751NALJ | 00643169503694 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR |