FDA Adverse Event
Malfunction
Summary report: N
OT VERIO IQ METER
MDR report key: 6474443
·
Received April 8, 2017
Report
- Report Number
- 3008382007-2017-16434
- Event Type
- Malfunction
- Date Received
- April 8, 2017
- Report Date
- March 15, 2017
- Manufacturer
- LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
- Product Code
- NBW
- UDI-DI
- 00353885008402
- PMA / PMN Number
- K110637
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
ON (B)(6) 2017, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING AN INACCURATE CONTROL SOLUTION RESULTS. THE REPORTER CLAIMED OBTAINING A CONTROL SOLUTION RESULT OF ¿124 125 163 165 117 121 120 132 130 122 142 139 AND 141 ¿ WHICH FELL OUT WITH THE SPECIFIED CONTROL SOLUTION RANGE PRINTED ON THE TEST STRIP VIAL. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED INACCURACY CONTROL 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 |
|---|---|---|---|---|---|---|---|
| 256305 | OT VERIO IQ METER | GLUCOSE MONITORING SYS/KIT | NBW | LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL | 4042677 | 00353885008402 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |