FDA Adverse Event
Injury
Summary report: N
PUMP MMT-722NAL PRDGM INS V2.2 CL EN PR
MDR report key: 1873066
·
Received October 15, 2010
Report
- Report Number
- 3004209178-2010-83129
- Event Type
- Injury
- Date Received
- October 15, 2010
- Date of Event
- October 2, 2010
- Report Date
- October 9, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS MED-REL
- 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 UNKNOWN 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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR LOW BLOOD GLUCOSE. THE NURSE STATED THAT THE DOCTOR REQUESTED A REPLACEMENT OF THE INSULIN PUMP. ALSO, IT WAS STATED THAT THE DOCTORS BELIEVED THE DEVICE WAS NOT FUNCTIONING PROPERLY, AND IT WAS CAUSING HER BLOOD GLUCOSE TO FLUCTUATE. NO FURTHER INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUMP MMT-722NAL PRDGM INS V2.2 CL EN PR | INFUSION PUMP | MDS | MEDTRONIC PUERTO RICO OPERATIONS MED-REL | MMT-722NAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR | Hospitalization |