FDA Adverse Event
Injury
Summary report: N
PUMP MMT-722RNAL PRDGM INS CL EN RC
MDR report key: 1872038
·
Received October 8, 2010
Report
- Report Number
- 2032227-2010-82885
- Event Type
- Injury
- Date Received
- October 8, 2010
- Date of Event
- September 18, 2010
- Report Date
- September 20, 2010
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- MDS
- PMA / PMN Number
- P980022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NURSE
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 REPORTED THAT SHE WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS, WITH BLOOD GLUCOSE LEVELS GREATER THAN 700 MG/DL. THE CUSTOMER TREATED BY BOLUSING, BUT HER BLOOD GLUCOSE LEVEL REMAINED ELEVATED. THE CUSTOMER'S DOCTOR WANTED THE INSULIN PUMP REPLACED. NO TROUBLESHOOTING WAS PERFORMED. NOTHING FURTHER WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUMP MMT-722RNAL PRDGM INS CL EN RC | INFUSION PUMP | MDS | MEDTRONIC MINIMED | MMT-722RNAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Hospitalization |