FDA Adverse Event
Injury
Summary report: N
PUMP MMT-512LNAB PRDGM INS BL EN US LN
MDR report key: 1031856
·
Received April 16, 2008
Report
- Report Number
- 2032227-2008-00648
- Event Type
- Injury
- Date Received
- April 16, 2008
- Date of Event
- March 29, 2008
- Report Date
- April 1, 2008
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- LZG
- PMA / PMN Number
- K030531
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, 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. AFTER TESTING, IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECS.
Description of Event or Problem · 1
THE CUSTOMER'S MOTHER STATED, THAT THE CUSTOMER WAS HAVING UNEXPLAINED HIGH BLOOD GLUCOSE LEVELS FOR A WEEK. THE MOTHER STATED, THAT THE CUSTOMER WAS HOSPITALIZED FOR HYPERGLYCEMIA, VOMITING AND DEHYDRATION. THE MOTHER WAS NOT COMFORTABLE HAVING HER DAUGHTER USE THE INSULIN PUMP AND ASKED TO HAVE IT REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUMP MMT-512LNAB PRDGM INS BL EN US LN | INFUSION PUMP | LZG | MEDTRONIC MINIMED | MMT-512LNAB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |