FDA Adverse Event
Malfunction
Summary report: N
OT PING ENHANCED METER
MDR report key: 2842386
·
Received November 21, 2012
Report
- Report Number
- 3008382007-2012-06581
- Event Type
- Malfunction
- Date Received
- November 21, 2012
- Report Date
- November 8, 2012
- Manufacturer
- LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
- Product Code
- NBW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PATIENT
Narratives
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 THE ANOTHER METER. THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF "22 MMOL/L" WITH A LIFESCAN METER AND "10 MMOL/L" ON ANOTHER METER, PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 30% AND/OR <= 30 MG/DL. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OT PING ENHANCED METER | GLUCOSE MONITORING SYS/KIT | NBW | LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |