BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT PING METER

    MDR report key: 3020502 · Received March 26, 2013

    Report

    Report Number
    3008382007-2013-06253
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    February 26, 2013
    Report Date
    March 1, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K082590
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE METER HAS PASSED TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE REPRODUCED. 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 ON (B)(6) 2013 AT APPROXIMATELY 9:30AM. SHE REPORTEDLY MANAGES HER DIABETES WITH INSULIN THROUGH PUMP THERAPY AND DENIED MAKING ANY CHANGES TO HER USUAL DIABETES MANAGEMENT ROUTINE IN RESPONSE TO THE ALLEGED ISSUE. APPROXIMATELY 1 HOUR LATER, SHE CLAIMED SHE DEVELOPED SYMPTOMS OF "FEELING THIRSTY" AND IN RESPONSE TO HER SYMPTOMS, SHE DRANK WATER. NO OTHER FORM OF TREATMENT WAS ADMINISTERED. AT THE TIME OF TROUBLESHOOTING, THE METER WAS NOT BEING USED FOR THE FIRST TIME. THE BATTERIES DID NOT NEED TO BE REPLACED BASED ON THE AGE/USE OF THE METER. THE CORRECT TEST STRIPS WERE BEING USED BUT THE ISSUE REMAINED UNRESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT AND SUBJECT PRODUCTS ARE PENDING RETURN FOR INVESTIGATION. THIS COMPLAINT IS BEING REPORTED BECAUSE, THE PATIENT CLAIMS SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124421 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3228349

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Life Threatening