FDA Adverse Event
Injury
Summary report: N
PUMP MMT-715NAS PRDGM INS V2.1 SK EN
MDR report key: 1031214
·
Received April 17, 2008
Report
- Report Number
- 3004209178-2008-00250
- Event Type
- Injury
- Date Received
- April 17, 2008
- Date of Event
- March 10, 2008
- Report Date
- April 2, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS MED-REL
- Product Code
- LZG
- PMA / PMN Number
- K040676
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ME, 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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.
Description of Event or Problem · 1
THE CUSTOMER STATED THAT SHE WAS TREATED BY THE PARAMEDICS FOR A LOW BLOOD GLUCOSE READING OF 28 MG/DL. THE CUSTOMER STATED THAT SHE REVIEWED HER BASAL RATES AND ONE OF THEM HAD BEEN CHANGED TO A HIGHER AMOUNT. THE CUSTOMER DID NOT RECALL EVER CHANGING THE BASAL RATES. THE CUSTOMER FELT VERY UNCOMFORTABLE WITH THE INSULIN PUMP AND ASKED TO HAVE IT REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUMP MMT-715NAS PRDGM INS V2.1 SK EN | INFUSION PUMP | LZG | MEDTRONIC PUERTO RICO OPERATIONS MED-REL | MMT-715NAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |