FDA Adverse Event
Malfunction
Summary report: N
OT ULTRALINK METER
MDR report key: 2871213
·
Received December 12, 2012
Report
- Report Number
- 3008382007-2012-08015
- Event Type
- Malfunction
- Date Received
- December 12, 2012
- Report Date
- November 28, 2012
- Manufacturer
- LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
- Product Code
- NBW
- PMA / PMN Number
- K073231
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
ON (B)(6) 2012, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING INACCURATE RESULTS. 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 ERRATIC COMPARED TO THE SAME METER. THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF "42 MG/DL" AND "83 MG/DL" WITH A LIFESCAN METER, PERFORMED WITHIN 20 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 20% AND/OR <= 20 MG/DL. 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 EUROPE, A DIVISION OF CILAG GMBH INTL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR |