FDA Adverse Event
Malfunction
Summary report: N
OT VERIO PRO METER
MDR report key: 2821635
·
Received November 6, 2012
Report
- Report Number
- 3008382007-2012-06041
- Event Type
- Malfunction
- Date Received
- November 6, 2012
- Report Date
- October 22, 2012
- Manufacturer
- LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
- Product Code
- NBW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
LIFESCAN (LFS) HAS NOT REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION.
Description of Event or Problem · 1
ON (B)(6) 2012, THE LAY USER/ PATIENT'S PHARMACIST CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THE ONETOUCH VERIO PRO METER READ INACCURATELY HIGH. THE PATIENT'S PHARMACIST DID NOT PROVIDE ANY BLOOD GLUCOSE VALUES. THE PATIENT'S PHARMACIST STATED THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS OR SEEK ANY MEDICAL ATTENTION BECAUSE OF THE REPORTED ISSUE. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE REMAINED UNRESOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OT VERIO PRO METER | GLUCOSE MONITORING SYS/KIT | NBW | LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |