FDA Adverse Event
Injury
Summary report: N
PUMP MMT-722NAP PRDGM INS V2.2 PL EN
MDR report key: 2971316
·
Received April 23, 2008
Report
- Report Number
- 3004209178-2008-09734
- Event Type
- Injury
- Date Received
- April 23, 2008
- Date of Event
- April 8, 2008
- Report Date
- April 11, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS MED-REL
- Product Code
- OYC
- PMA / PMN Number
- P980022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE INSULIN PUMP PASSED THE DISPLACEMENT, REWIND, BASIC OCCLUSION, PRIME AND EXCESSIVE NO DELIVERY TESTS. THE DISPLAY WAS MISSING SEGMENTS DUE TO A FAULTY LCD DISPLAY.
Description of Event or Problem · 1
THE CUSTOMER STATED, SHE WAS HOSPITALIZED DUE TO HYPERGLYCEMIA. THE BLOOD GLUCOSE READING AT THE TIME OF THE EVENT WAS NOT REPORTED. IT WAS REPORTED THAT THE DISPLAY WAS MISSING SEGMENTS. TROUBLESHOOTING WAS NOT PERFORMED FOR THE HYPERGLYCEMIA BECAUSE OF THE DISPLAY ANOMALY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUMP MMT-722NAP PRDGM INS V2.2 PL EN | INFUSION PUMP | OYC | MEDTRONIC PUERTO RICO OPERATIONS MED-REL | MMT-722NAP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR | Hospitalization |