FDA Adverse Event
Injury
Summary report: N
PUMP MMT-722NAS PRDGM INS V2.2 SK EN
MDR report key: 1033876
·
Received April 24, 2008
Report
- Report Number
- 2032227-2008-00705
- 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
- P980022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.
Description of Event or Problem · 1
THE CUSTOMER STATED THAT HE WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE AND THE READING WAS 970 MG/DL. THE CUSTOMER WAS VOMITING, HAD KETONES AND HAD PAIN IN HIS BONES. THE CUSTOMER DECLINED ALL TROUBLESHOOTING AND ONLY WANTED THE INSULIN PUMP REPLACED. THE CUSTOMER STATED THAT THE HOSPITAL WOULD ONLY RELEASE HIM IF THE INSULIN PUMP WAS REPLACED. NOTHING FURTHER WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUMP MMT-722NAS PRDGM INS V2.2 SK EN | INFUSION PUMP | LZG | MEDTRONIC MINIMED | MMT-722NAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |