FDA Adverse Event
Injury
Summary report: N
PUMP MMT-712LNAL PRDGM INS CL EN US LN
MDR report key: 1033867
·
Received April 24, 2008
Report
- Report Number
- 2032227-2008-00703
- Event Type
- Injury
- Date Received
- April 24, 2008
- Date of Event
- April 11, 2008
- Report Date
- April 11, 2008
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- LZG
- PMA / PMN Number
- K031390
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, 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 SPECIFICATIONS.
Description of Event or Problem · 1
THE CUSTOMER STATED THAT SHE WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS WITH BLOOD GLUCOSE LEVELS OVER 550 MG/DL. NO TROUBLESHOOTING WAS DONE ON THE INSULIN PUMP BECAUSE THE CUSTOMER DID NOT HAVE ANY SUPPLIES WITH HER. THE CUSTOMER STATED THAT SHE WAS GETTING NO DELIVERY ALARMS DURING THE PRIMING PROCESS. NOTHING FURTHER WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUMP MMT-712LNAL PRDGM INS CL EN US LN | INFUSION PUMP | LZG | MEDTRONIC MINIMED | MMT-712LNAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |