FDA Adverse Event
Injury
Summary report: N
PUMP MMT-722LNAB PRDGM INS BL EN ML
MDR report key: 1052828
·
Received May 27, 2008
Report
- Report Number
- 2032227-2008-00889
- Event Type
- Injury
- Date Received
- May 27, 2008
- Date of Event
- May 12, 2008
- Report Date
- May 13, 2008
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- LZG
- PMA / PMN Number
- P980022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
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. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.
Description of Event or Problem · 1
THE CUSTOMER'S MOTHER STATED THAT THE CUSTOMER WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE LEVELS. NO BLOOD GLUCOSE READING WAS REPORTED. THE CUSTOMER'S MOTHER ALSO STATED THAT CUSTOMER WAS GETTING NO DELIVERY ALARMS PRIOR TO THE HOSPITALIZATION. NOTHING FURTHER WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUMP MMT-722LNAB PRDGM INS BL EN ML | INFUSION PUMP | LZG | MEDTRONIC MINIMED | MMT-722LNAB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |