FDA Adverse Event
Injury
Summary report: N
PUMP MMT-523NAP PRDGM INSULIN PURPLE
MDR report key: 1873684
·
Received October 13, 2010
Report
- Report Number
- 3004209178-2010-83092
- Event Type
- Injury
- Date Received
- October 13, 2010
- Date of Event
- September 30, 2010
- Report Date
- October 2, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS MED-REL
- Product Code
- MDS
- PMA / PMN Number
- P980022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED RECEIVING NO DELIVERY ALARMS. DURING THE CALL, THE CUSTOMER ALSO REPORTED BEING HOSPITALIZED FOR HIGH BLOOD GLUCOSE OF 417MG/DL. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER TREATED HER GLUCOSE LEVEL WITH MANUAL INJECTIONS. RAN A HIGH PRESSURE TEST AND THE INSULIN PUMP PASSED THE TEST. NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUMP MMT-523NAP PRDGM INSULIN PURPLE | INFUSION PUMP | MDS | MEDTRONIC PUERTO RICO OPERATIONS MED-REL | MMT-523NAP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Hospitalization |