BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 3982419 · Received August 6, 2014

    Report

    Report Number
    2939301-2014-19702
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Report Date
    July 23, 2014
    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
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE PATIENT CONTACTED LIFESCAN (LFS) USA ALLEGING THAT THEIR ONE TOUCH PING METER HAD ISSUES WITH THE OK BUTTON. THE OK BUTTON WAS STUCK/STICKING AND WAS UNRESPONSIVE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED BUTTON ISSUE FIRST OCCURRED ON (B)(6) 2014. THE PATIENT MANAGES THEIR DIABETES WITH AN UNKNOWN TYPE AND DOSAGE OF INSULIN AND DENIED TAKING ANY ACTION IN RESPONSE TO THEIR REGULAR DIABETES MANAGEMENT REGIMEN ROUTINE AS A RESULT OF THE BUTTON ISSUE. THE PATIENT DENIED EXPERIENCING ANY SYMPTOMS AS A RESULT OF THE BUTTON ISSUE. AT 9AM ON (B)(6) 2014 THE PATIENT VISITED THE EMERGENCY ROOM (E.R) WHERE THEY RECEIVED ANTIBIOTICS FOR AN UNRELATED KIDNEY INFECTION. THE PATIENT'S BLOOD GLUCOSE WAS MEASURED ON AN UNKNOWN E.R METER BETWEEN (B)(6) 2014 AND OBTAINED BLOOD GLUCOSE RESULTS OF ¿300-400MG/DL¿ DURING THIS TIME PERIOD. AT THE TIME OF TROUBLESHOOTING THE CCA NOTED THAT THE OK BUTTON WAS STUCK/STICKING AND WAS ALSO UNRESPONSIVE. THERE WAS NO MISUSE OF THE PRODUCT, AND THE ISSUE COULD NOT BE RESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THERE IS NO INDICATION THE METER ISSUE CAUSED AND/OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT DID NOT DEVELOP SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA OR HYPERGLYCEMIA, NOR DID THEY RECEIVE MEDICAL INTERVENTION FOR EITHER OF THESE CONDITIONS. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED BUTTON ISSUE REMAINED UNRESOLVED AT THE TIME OF TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461554 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3364078

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR