BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 3040968 · Received April 8, 2013

    Report

    Report Number
    3008382007-2013-07220
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Report Date
    March 12, 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
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH PING METER WAS DISPLAYING A BATTERY INDICATOR. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT ALLEGED THAT THE ISSUE FIRST BEGAN TWO MONTHS PRIOR TO CONTACTING LFS. ACCORDING TO THE CSR'S DOCUMENTATION, 30 MINUTES PRIOR TO THE START OF THE ALLEGED ISSUE, THE PATIENT REPORTEDLY WAS EXPERIENCING SYMPTOMS OF THIRST AND URINATION. THE PATIENT, HOWEVER, DENIED RECEIVING ANY FORM OF MEDICAL INTERVENTION AFTER THE ALLEGED POWER ISSUE OCCURRED. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THE PATIENT WAS CHANGING THE SUBJECT METER'S BATTERIES EVERY TWO WEEKS DUE TO THE ALLEGED ISSUE. REPLACEMENT METER WAS SENT TO THE PATIENT. THERE IS NO EVIDENCE THAT THE PRODUCT CAUSED OR CONTRIBUTED TO A SERIOUS INJURY BECAUSE THE PATIENT REPORTEDLY SUFFERED SYMPTOMS PRIOR TO THE ALLEGED PRODUCT ISSUE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED PRODUCT ISSUE WAS NOT RESOLVED DURING TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142994 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1