FDA Adverse Event
Injury
Summary report: N
PUMP MMT-515LNAP PRDGM INS V2.1 PL EN
MDR report key: 1780969
·
Received July 27, 2010
Report
- Report Number
- 2032227-2010-82027
- Event Type
- Injury
- Date Received
- July 27, 2010
- Date of Event
- July 4, 2010
- Report Date
- July 4, 2010
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- LZG
- PMA / PMN Number
- K040676
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- 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
IT WAS STATED THAT THE CUSTOMER WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE LEVELS, WITH A READING OF 600 MG/DL. PRIOR TO THE EVENT, THE CUSTOMER RECEIVED MULTIPLE NO DELIVERY ALARMS DURING BOLUS ATTEMPTS. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP PASSED THE PRIME TEST. NOTHING FURTHER WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUMP MMT-515LNAP PRDGM INS V2.1 PL EN | INFUSION PUMP | LZG | MEDTRONIC MINIMED | MMT-515LNAP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 21 YR | Hospitalization |