FDA Adverse Event
Injury
Summary report: N
PUMP MMT-722NAL PRDGM INS V2.2 CL EN PR
MDR report key: 1853323
·
Received September 29, 2010
Report
- Report Number
- 2032227-2010-82818
- Event Type
- Injury
- Date Received
- September 29, 2010
- Date of Event
- September 6, 2010
- Report Date
- September 13, 2010
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- MDS
- PMA / PMN Number
- P980022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NURSE
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 ALSO HAD A CRACKED CASE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR LOW BLOOD GLUCOSE LEVELS, WITH A READING OF 27 MG/DL. THE NURSE FELT THAT THE INSULIN PUMP WAS NOT ACCOUNTING FOR ACTIVE INSULIN. TROUBLESHOOTING WAS PERFORMED, AND FOUND THAT THE CUSTOMER WASN'T USING THE BOLUS WIZARD FEATURE. THIS IS WHY THE INSULIN PUMP WASN'T ACCOUNTING FOR ACTIVE INSULIN. IT WAS ALSO STATED THAT THE INSULIN PUMP HAD A CRACK ON THE SCREEN. ADVISED THAT THE INSULIN PUMP WOULD BE REPLACED. NOTHING FURTHER WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUMP MMT-722NAL PRDGM INS V2.2 CL EN PR | INFUSION PUMP | MDS | MEDTRONIC MINIMED | MMT-722NAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Hospitalization |