FDA Adverse Event
Malfunction
Summary report: N
PUMP MMT-722NAS PRDGM INS V2.2 SK EN
MDR report key: 1972533
·
Received December 30, 2010
Report
- Report Number
- 3004209178-2010-83709
- Event Type
- Malfunction
- Date Received
- December 30, 2010
- Date of Event
- December 2, 2010
- Report Date
- December 2, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS MED-REL
- Product Code
- MDS
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, 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 INCLUDING THE DISPLACEMENT TEST. AFTER TESTING, IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CUSTOMER WAS EXPERIENCING LOW BLOOD GLUCOSE FOR A WEEK. THE MOTHER STATED THAT THE BASAL RATES ON THE INSULIN PUMP WERE REDUCED. TROUBLESHOOTING WAS PERFORMED. THE BOLUS HISTORY REVEALED TWO BOLUSES, WHICH THE CUSTOMER DID NOT DELIVER WHILE THE INSULIN PUMP WAS ON SUSPEND MODE. RAN A DISPLACEMENT TEST AND THE DEVICE PASSED THE TEST. NO FURTHER INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUMP MMT-722NAS PRDGM INS V2.2 SK EN | INFUSION PUMP | MDS | MEDTRONIC PUERTO RICO OPERATIONS MED-REL | MMT-722NAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 12 YR |