FDA Adverse Event
Injury
Summary report: N
PUMP MMT-722NAB PRDGM INS V2.2 BL EN
MDR report key: 1780295
·
Received July 26, 2010
Report
- Report Number
- 3004209178-2010-82167
- Event Type
- Injury
- Date Received
- July 26, 2010
- Date of Event
- July 9, 2010
- Report Date
- July 10, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS MED-REL
- Product Code
- LZG
- PMA / PMN Number
- P980022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
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. IT WAS STATED THAT THE CUSTOMER MAY HAD OVER BOLUSED GIVING 25U OF INSULIN IN A LAPSE OF EIGHT HOURS. THE BLOOD GLUCOSE READING WAS 17 MG/DL. IT WAS REPORTED THAT THE TRANSMITTER MAY HAVE BEING BROKEN AND DID NOT GIVE A GOOD RESULTS, BUT THE INSULIN PUMP WAS OK. IT WAS ALSO REPORTED THAT THE CUSTOMER DOES NOT CHECK HIS BLOOD GLUCOSE REGULARLY. NO FURTHER INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUMP MMT-722NAB PRDGM INS V2.2 BL EN | INFUSION PUMP | LZG | MEDTRONIC PUERTO RICO OPERATIONS MED-REL | MMT-722NAB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 20 YR | Hospitalization |