FDA Adverse Event
Injury
Summary report: N
PUMP MMT-523NAB PRDGM INSULIN BLUE
MDR report key: 1915822
·
Received November 30, 2010
Report
- Report Number
- 3004209178-2010-83445
- Event Type
- Injury
- Date Received
- November 30, 2010
- Date of Event
- November 16, 2010
- Report Date
- November 16, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS MED-REL
- Product Code
- MDS
- PMA / PMN Number
- P980022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, 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
IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE. THE BLOOD GLUCOSE READING AT TIME OF THE CALL WAS 511MG/DL. TROUBLESHOOTING WAS PERFORMED. RAN A FIXED PRIME TEST AND THE DEVICE PASSED THE TEST. THE MOTHER STATED THAT THE CUSTOMER WAS TAKEN TO THE HOSPITAL WHEN THE BLOOD GLUCOSE METER READ OVER 600 MG/DL. NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUMP MMT-523NAB PRDGM INSULIN BLUE | INFUSION PUMP | MDS | MEDTRONIC PUERTO RICO OPERATIONS MED-REL | MMT-523NAB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 4 YR | Hospitalization |