FDA Adverse Event
Injury
Summary report: N
PUMP MMT-715LNAL PRDGM INS V2.1 CL EN
MDR report key: 1872050
·
Received October 8, 2010
Report
- Report Number
- 2032227-2010-82877
- Event Type
- Injury
- Date Received
- October 8, 2010
- Date of Event
- September 19, 2010
- Report Date
- September 20, 2010
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- LZG
- PMA / PMN Number
- K040676
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, 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 HE WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE LEVELS, WITH A READING OF 511 MG/DL. PRIOR TO THE EVENT, THE CUSTOMER WAS EXPERIENCING NO DELIVERY ALARMS. NOTHING FURTHER WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUMP MMT-715LNAL PRDGM INS V2.1 CL EN | INFUSION PUMP | LZG | MEDTRONIC MINIMED | MMT-715LNAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Hospitalization |