FDA Adverse Event
Injury
Summary report: N
530G INSULIN PUMP
MDR report key: 4143331
·
Received September 27, 2014
Report
- Report Number
- 2032227-2014-30003
- Event Type
- Injury
- Date Received
- September 27, 2014
- Date of Event
- August 28, 2014
- Report Date
- August 29, 2014
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- OZO
- PMA / PMN Number
- 120010
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PUMP PASSED ALL FUNCTIONAL TESTING INCLUDING THE DISPLACEMENT, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME A33 AND EXCESSIVE NO DELIVERY TEST. NO EXCESSIVE NO DELIVERY ALARM NOTED. PUMP RECEIVED WITH CRACKED RESERVOIR TUBE LIP AND SCRATCHED LCD WINDOW. (B)(4).
Description of Event or Problem · 1
CUSTOMER'S WIFE REPORTS THAT CUSTOMER WAS HOSPITALIZED DUE TO DIABETIC ULCER. CUSTOMER WAS ADVISED BY HEALTHCARE PROVIDER THAT INSULIN PUMP NEEDS TO BE REPLACED EVEN THOUGH PROBLEM WAS SOLVED THROUGH TROUBLESHOOTING WITH NURSE. DETAILS OF HOSPITALIZATION NOT PROVIDED. INSULIN PUMP WOULD BE REPLACED. NO FURTHER INFORMATION PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 603559 | 530G INSULIN PUMP | OZO | MEDTRONIC MINIMED | MMT-751NAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Hospitalization |