BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 3220463 · Received July 11, 2013

    Report

    Report Number
    3008382007-2013-19285
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Report Date
    June 20, 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
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ (10/01/2013). THE PATIENT¿S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 9/11/2013 AND 9/24/2013, RESPECTIVELY, WITH THE FOLLOWING FINDINGS:THE METER INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE METER WAS FOUND TO HAVE A LOW BATTERY. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2013 THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH PING METER WAS NOT POWERING ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE¿S (CCA) DOCUMENTATION. THE PATIENT CLAIMED THE ALLEGED ISSUE BEGAN AT APPROXIMATELY 12 PM ON THE SAME DAY SHE CONTACTED LFS FOR ASSISTANCE. THE PATIENT REPORTEDLY MANAGES HER DIABETES WITH INSULIN (UNKNOWN TYPE) THROUGH PUMP THERAPY AND DENIED MAKING ANY CHANGES TO HER MEDICATION. SHE CLAIMED THAT 1 HOUR BEFORE THE ISSUE BEGAN; SHE WAS EXPERIENCING SYMPTOMS OF ¿FEELING SHAKY AND WEAK.¿ IMMEDIATELY AFTER ATTEMPTING TO TEST WITH THE SUBJECT DEVICE AT 12 PM, SHE SELF TREATED WITH CANDY. SHE REPORTED THAT SHE TESTED USING ANOTHER METER (BRAND UNKNOWN) AT APPROXIMATELY 1 PM AND OBTAINED A READING OF ¿142 MG/DL.¿ AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE SUBJECT DEVICE WAS NOT BRAND NEW. THE PATIENT WAS USING THE CORRECT TEST STRIPS. THE BATTERY WAS RECENTLY REPLACED BUT THE ISSUE REMAINED UNRESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT AND SUBJECT PRODUCTS ARE PENDING RETURN FOR INVESTIGATION. THERE IS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT¿S SYMPTOMS STARTED BEFORE THE REPORTED ISSUE FIRST OCCURRED AND THERE IS NO EVIDENCE THE PATIENT ADMINISTERED INAPPROPRIATE SELF TREATMENT DUE TO THE ALLEGED ISSUE. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED PRODUCT ISSUE REMAINED UNRESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319575 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3249632

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR