OT PING METER
Report
- Report Number
- 2939301-2012-03242
- Event Type
- Malfunction
- Date Received
- April 3, 2012
- Report Date
- March 20, 2012
- Manufacturer
- LIFESCAN INC.
- Product Code
- NBW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PATIENT
Narratives
THE 510(K) # IS K080639.
ON (B)(6) 2012, THE REPORTER CONTACTED LIFESCAN ALLEGING THE METER HAD DATE/TIME ISSUES. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON CUSTOMER SERVICE INVESTIGATIONS, THIS COMPLAINT WAS INITIALLY RULED OUT BECAUSE THIS MALFUNCTION IS NOT CONSIDERED REPORTABLE AS LIFESCAN DOES NOT BELIEVE THE CHANCE THIS MALFUNCTION CAUSING OR CONTRIBUTING TO AN AE IS MORE THAN REMOTE AND HAS NOT REPORTED AN AE WHERE THIS MALFUNCTION MAY HAVE CAUSED OR CONTRIBUTED TO THE INJURY/DEATH. THERE WERE ALSO NO ALLEGATIONS OF HARM OR INJURY. ON (B)(4) 2012, LIFESCAN COMPLETED DEVICE EVALUATION WITH THE METER INVOLVED WITH THIS COMPLAINT. INVESTIGATION FOUND THAT THE BATTERIES VOLTAGE WAS LOW/DEAD. WHEN THE BATTERY WAS REPLACED, THE METER POWERED ON WITH A LINE THROUGH THE DISPLAY. THE LCD WAS REPLACED AND THE METER'S DATE WAS FOUND TO BE SET TO THE YEAR 2013. THE DATE/TIME ISSUE REMAINS NON REPORTABLE AS LIFESCAN (1) DOES NOT BELIEVE THE CHANCE THIS MALFUNCTION CAUSING OR CONTRIBUTING TO AN AE IS MORE THAN REMOTE AND (2) HAS NOT REPORTED AN AE WHERE THIS MALFUNCTION MAY HAVE CAUSED OR CONTRIBUTED TO THE INJURY/DEATH. HOWEVER, THIS COMPLAINT IS NOW BEING REPORTED DUE TO THE DEFECTIVE LCD ISSUE FOUND DURING INVESTIGATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OT PING METER | GLUCOSE MONITORING SYS/KIT | NBW | LIFESCAN INC. | 3230353 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |