FDA Adverse Event
Injury
Summary report: N
PUMP MMT-523RNAP PRDGM INS V2.3 PL EN RC
MDR report key: 1872045
·
Received October 8, 2010
Report
- Report Number
- 2032227-2010-82893
- Event Type
- Injury
- Date Received
- October 8, 2010
- Date of Event
- September 21, 2010
- Report Date
- September 21, 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
CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE LEVELS. THE NURSE WANTED TO REVIEW THE BASAL RATES, BUT SHE HAD TO HANG UP SUDDENLY, AND NO FURTHER INFO WAS OBTAINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUMP MMT-523RNAP PRDGM INS V2.3 PL EN RC | INFUSION PUMP | MDS | MEDTRONIC MINIMED | MMT-523RNAP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Hospitalization |