BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 2515521 · Received April 3, 2012

    Report

    Report Number
    2939301-2012-03244
    Event Type
    Malfunction
    Date Received
    April 3, 2012
    Report Date
    March 22, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510(K) # IS K080639.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THE METER WAS MISSING RESULTS. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT WAS INITIALLY RULED OUT DUE TO THE FOLLOWING CONCLUSIONS: THIS MALFUNCTION IS NOT CONSIDERED 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. THERE WERE ALSO NO ALLEGATIONS OF HARM OR INJURY. ON (B)(6) 2012, LIFESCAN COMPLETED DEVICE EVALUATIONS WITH THE METER INVOLVED WITH THIS COMPLAINT. THE ALLEGED COMPLAINT WAS NOT CONFIRMED; HOWEVER, A SECONDARY ISSUE WAS FOUND DURING TESTING. THE METER WAS FOUND TO HAVE A DEFECTIVE LCD. THIS COMPLAINT IN NOW BEING REPORTED DUE TO THE SECONDARY ISSUE FOUND DURING TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC.

    Patients

    Seq Age Sex Outcome Treatment
    1