FDA Adverse Event
Injury
Summary report: N
PUMP MMT-522NAB PRDGM INS V2.2 BL EN
MDR report key: 1812001
·
Received August 17, 2010
Report
- Report Number
- 2032227-2010-82366
- Event Type
- Injury
- Date Received
- August 17, 2010
- Date of Event
- July 23, 2010
- Report Date
- July 23, 2010
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- MDS
- PMA / PMN Number
- P980022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING, IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS. THE INSULIN PUMP HAD A CRACKED RESERVOIR TUBE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED SEVERAL BATTERY RELATED ISSUES. THE CUSTOMER ALSO STATED THAT SHE HAD TO GO TO THE HOSPITAL FOR ASSISTANCE DUE TO THESE ISSUES. NOTHING FURTHER WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUMP MMT-522NAB PRDGM INS V2.2 BL EN | INFUSION PUMP | MDS | MEDTRONIC MINIMED | MMT-522NAB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Hospitalization |