FDA Adverse Event
Injury
Summary report: N
PUMP MMT-722NAL PRDGM INSULIN CL EN
MDR report key: 1931204
·
Received December 10, 2010
Report
- Report Number
- 2032227-2010-83406
- Event Type
- Injury
- Date Received
- December 10, 2010
- Date of Event
- November 24, 2010
- Report Date
- November 24, 2010
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- MDS
- PMA / PMN Number
- P980022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, 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 AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND 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 REPORTED THAT HE WAS HOSPITALIZED TWICE FOR HIGH BLOOD GLUCOSE LEVELS DUE TO BENT CANNULAS. ONCE (B)(6) 2010 WITH A BLOOD GLUCOSE READING OF 450 MG/DL AND AGAIN (B)(6) 2010 WITH A BLOOD GLUCOSE READING OF 513 MG/DL. THE CUSTOMER'S MOTHER DID NOT WANT TO TROUBLESHOOT, AND REQUESTED A REPLACEMENT INSULIN PUMP. NOTHING FURTHER WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUMP MMT-722NAL PRDGM INSULIN CL EN | INFUSION PUMP | MDS | MEDTRONIC MINIMED | MMT-722NAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 17 YR | Hospitalization |