FDA Adverse Event
Malfunction
Summary report: N
OT PING METER
MDR report key: 2890093
·
Received December 28, 2012
Report
- Report Number
- 3008382007-2012-09117
- Event Type
- Malfunction
- Date Received
- December 28, 2012
- Report Date
- December 7, 2012
- Manufacturer
- LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
- Product Code
- NBW
- PMA / PMN Number
- K082590
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
ON (B)(6) 2012, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING AN INACCURACY 3 YEARS PRIOR. IT WAS NOTED THAT THE PATIENT COMPARED A RESULT OBTAINED WITH THE SUBJECT METER COMPARED TO THE LAB. THE PATIENT DID NOT RECALL THE BLOOD GLUCOSE READING OBTAINED EITHER ON THE SUBJECT METER OR ON THE LABORATORY DEVICE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED INACCURACY ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OT PING METER | GLUCOSE MONITORING SYS/KIT | NBW | LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL | 3321020 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR |