FDA Adverse Event
Injury
Summary report: N
PUMP MMT-712RNAS PRDGM INS SK EN US RC
MDR report key: 1060259
·
Received June 11, 2008
Report
- Report Number
- 2032227-2008-00975
- Event Type
- Injury
- Date Received
- June 11, 2008
- Date of Event
- May 28, 2008
- Report Date
- May 29, 2008
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- LZG
- PMA / PMN Number
- K031390
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.
Description of Event or Problem · 1
IT WAS STATED THAT THE CUSTOMER WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS WITH A BLOOD GLUCOSE READING OF 789 MG/DL. CHECKED THE ALARM HISTORY AND FOUND ONLY NO DELIVERY ALARMS. THE PHYSICIAN'S ASSISTANT FELT THAT THE INSULIN PUMP WAS FAULTY AND ASKED TO HAVE IT REPLACED. NOTHING FURTHER WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUMP MMT-712RNAS PRDGM INS SK EN US RC | INFUSION PUMP | LZG | MEDTRONIC MINIMED | MMT-712RNAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |