BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 3132065 · Received May 29, 2013

    Report

    Report Number
    3008382007-2013-13069
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Report Date
    May 2, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K082590
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION FOLLOW-UP # (B)(4) 2013. INCIDENT DESCRIPTION: BLANK. EVENT TYPE: REPORTABLE TYPE: RULED OUT. PI CLASSIFICATION: NON-REPORTABLE. NOTES PER (B)(4), SMARTSCRIPT ERROR RESULTED IN INCORRECTLY FLAGGING PI AS A MALFUNCTION. UPDATING REPORTABLE TYPE TO RULED OUT AND THE PI CLASSIFICATION TO NON-REPORT

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING BATTERY INDICATOR. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED 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
    236399 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3331074

    Patients

    Seq Age Sex Outcome Treatment
    1