FDA Adverse Event
Injury
Summary report: N
PUMP MMT-712NAL PRDGM INSULIN CL EN
MDR report key: 1870113
·
Received October 11, 2010
Report
- Report Number
- 2032227-2010-82902
- Event Type
- Injury
- Date Received
- October 11, 2010
- Date of Event
- September 22, 2010
- Report Date
- September 22, 2010
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- LGZ
- PMA / PMN Number
- K031390
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, 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. 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 REPORTED THAT SHE WAS EXPERIENCING HIGH BLOOD GLUCOSE LEVELS THAT ARE NOT RESPONDING TO BOLUSES. THE CUSTOMER'S BLOOD GLUCOSE LEVELS WERE TOO HIGH FOR HER GLUCOSE METER TO READ. ADVISED THE CUSTOMER TO SEEK MEDICAL ASSISTANCE, AND SHE STATED THAT SHE WOULD HAVE HER SONS TAKE HER OR USE HER MED ALERT. CALLED THE CUSTOMER TO FOLLOW UP WITH HER, BUT THERE WAS NO ANSWER. NOTHING FURTHER WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUMP MMT-712NAL PRDGM INSULIN CL EN | INFUSION PUMP | LGZ | MEDTRONIC MINIMED | MMT-712NAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Hospitalization |