FDA Adverse Event
Injury
Summary report: N
PUMP MMT-722NAB PRDGM INS V2.2 BL EN
MDR report key: 1811971
·
Received August 17, 2010
Report
- Report Number
- 3004209178-2010-82504
- Event Type
- Injury
- Date Received
- August 17, 2010
- Date of Event
- July 25, 2010
- Report Date
- July 26, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS MED-REL
- Product Code
- LZG
- PMA / PMN Number
- P980022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, 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. IN ADDITION, THE DEVICE HAD A BROKEN RESERVOIR TUBE LIP. AFTER TESTING, IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR DIABETES KETOACIDOSIS. THE BLOOD GLUCOSE READING WAS 585 MG/DL. THE MOTHER STATED THAT THE INSULIN PUMP ALARMED REPEATEDLY NO DELIVERY, AND THE INFUSION SET WAS CHANGED SEVERAL TIMES. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT THE CASE WAS CHIPPED. NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUMP MMT-722NAB PRDGM INS V2.2 BL EN | INFUSION PUMP | LZG | MEDTRONIC PUERTO RICO OPERATIONS MED-REL | MMT-722NAB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 16 YR | Hospitalization |