FDA Adverse Event
Malfunction
Summary report: N
530G INSULIN PUMP
MDR report key: 6097421
·
Received November 11, 2016
Report
- Report Number
- 2032227-2016-41466
- Event Type
- Malfunction
- Date Received
- November 11, 2016
- Date of Event
- October 20, 2016
- Report Date
- October 20, 2016
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OZO
- PMA / PMN Number
- 120010
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
INSULIN PUMP RECEIVED WITH CRACKED AND BLEEDING LCD GLASS, MINOR SCRATCHED DISPLAY WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNERS, CRACKED BATTERY TUBE THREADS, CRACKED RESERVOIR TUBE LIP. (B)(4).
Description of Event or Problem · 1
CUSTOMER REPORTED VIA PHONE CALL THAT THE INK ON THE SCREEN CRACKED. CUSTOMER'S BLOOD GLUCOSE WAS 208 MG/DL. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACK-UP PLAN PER HEALTH CARE PROFESSIONALS' INSTRUCTIONS. CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WILL BE REPLACED. CUSTOMER AGREED TO RETURN THE DEVICE FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 747739 | 530G INSULIN PUMP | OZO | OZO | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-751NAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 16 YR |