FDA Adverse Event
Malfunction
Summary report: N
OT VERIO METER
MDR report key: 3163050
·
Received June 11, 2013
Report
- Report Number
- 3008382007-2013-16675
- Event Type
- Malfunction
- Date Received
- June 11, 2013
- Report Date
- May 29, 2013
- Manufacturer
- LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
- Product Code
- NBW
- PMA / PMN Number
- K093745
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
ON (B)(6) 2013, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THE ONETOUCH VERIO METER READ INACCURATELY COMPARED TO ANOTHER DEVICE. THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF ¿8MMOL/L¿ WITH THE SUBJECT METER AND ¿6 MMOL/L¿ ON ANOTHER METER, PERFORMED WITHIN 30 MINUTES OF EACH OTHER. THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS OR SEEK ANY MEDICAL ATTENTION BECAUSE OF THE REPORTED ISSUE. AS THE RESULTS FELL OUTSIDE EXPECTED VALUES FOR METER TO METER ACCURACY TESTING, THIS COMPLAINT IS BEING REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 264244 | OT VERIO METER | GLUCOSE MONITORING SYS/KIT | NBW | LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL | 3387579 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR |