FDA Adverse Event
Malfunction
Summary report: N
OT PING METER
MDR report key: 5222169
·
Received November 13, 2015
Report
- Report Number
- 2939301-2015-48756
- Event Type
- Malfunction
- Date Received
- November 13, 2015
- Report Date
- November 5, 2015
- 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
- NY, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
ON (B)(6) 2015, THE REPORTER CONTACTED LIFESCAN USA ALLEGING THAT THE SUBJECT METER READ INACCURATELY ERRATIC. THE REPORTER CLAIMED OBTAINING BLOOD GLUCOSE READINGS OF "38 AND HI MG/DL" WITH THE SUBJECT METER, PERFORMED WITHIN 20 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS LIFESCAN'S CRITERIA FOR ACCURACY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED 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 |
|---|---|---|---|---|---|---|---|
| 752506 | OT PING METER | GLUCOSE MONITORING SYS/KIT | NBW | LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL | 3815532 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |