FDA Adverse Event
Malfunction
Summary report: N
OT ULTRALINK METER
MDR report key: 2810902
·
Received October 31, 2012
Report
- Report Number
- 2939301-2012-12541
- Event Type
- Malfunction
- Date Received
- October 31, 2012
- Report Date
- October 18, 2012
- Manufacturer
- LIFESCAN INC.
- Product Code
- NBW
- PMA / PMN Number
- K073231
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
NO PRODUCT IS EXPECTED TO BE RETURNED.
Description of Event or Problem · 1
THERE IS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE A PATIENT CONTACTED LIFESCAN ALLEGING THAT THE SUBJECT METER READ INACCURATELY LOW COMPARED TO ANOTHER METER. THE PATIENT OBTAINED BLOOD GLUCOSE RESULTS OF 132 MG/DL WITH ANOTHER METER AND AN UNSPECIFIED RESULT FROM A LIFESCAN METER, PERFORMED WITHIN 30 MINUTES OF EACH OTHER. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OT ULTRALINK METER | GLUCOSE MONITORING SYS/KIT | NBW | LIFESCAN INC. | 3348132 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |