FDA Adverse Event
Injury
Summary report: N
PUMP MMT-515NAS PRDGM INS V2.1 SK EN
MDR report key: 3040301
·
Received November 12, 2007
Report
- Report Number
- 3004209178-2007-04750
- Event Type
- Injury
- Date Received
- November 12, 2007
- Date of Event
- October 29, 2007
- Report Date
- October 29, 2007
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS MEDL-REL
- Product Code
- OYC
- PMA / PMN Number
- K040676
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE CUSTOMER'S SISTER CALLED AND STATED THAT THE CUSTOMER EXPERIENCED LOW BLOOD GLUCOSE AND REQUIRED MEDICAL ASSISTANCE BY THE PARAMEDICS. IT WAS STATED THAT THE CUSTOMER GAVE A BOLUS PRIOR TO THE EVENT, BUT SHE FORGOT THAT SHE GAVE THAT BOLUS AND THEN SHE BOLUSED AGAIN. TROUBLESHOOTING WAS DECLINED BECAUSE THE LOW BLOOD GLUCOSE EVENT WAS EXPLAINED AS USER ERROR. THE REPORTED BLOOD GLUCOSE READING WAS 149 MG/DL DURING THE PHONE CALL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUMP MMT-515NAS PRDGM INS V2.1 SK EN | INFUSION PUMP | OYC | MEDTRONIC PUERTO RICO OPERATIONS MEDL-REL | MMT-515NAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Hospitalization |