BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 4191624 · Received October 22, 2014

    Report

    Report Number
    2939301-2014-28321
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Report Date
    October 15, 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
    IN, 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 LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT THEIR ONETOUCH PING METER WAS POWERING OFF DURING USE. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT ALLEGED THAT THE PRODUCT ISSUE BEGAN ON (B)(6) 2014 AT 11AM. THE PATIENT MANAGES THEIR DIABETES WITH AN INSULIN PUMP AND REPORTED TAKING THEIR USUAL DOSE OF NOVALOG AFTER THE PRODUCT ISSUE BEGAN. THE PATIENT REPORTED DEVELOPING A SYMPTOM OF ¿HEADACHE¿ AFTER THE PRODUCT ISSUE BEGAN BUT COULD NOT RECALL HOW MUCH TIME HAD PASSED. THE PATIENT DENIED RECEIVING ANY TREATMENT FOR THIS SYMPTOM. AT THE TIME OF TROUBLESHOOTING THE CSR VERIFIED THAT THERE WAS NO MISUSE OF THE PRODUCT AND THAT THE BATTERIES DID NOT NEED TO BE REPLACED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THERE IS NO INDICATION THAT THE REPORTED ISSUE CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT¿S REPORTED SYMPTOM DOES NOT MEET LFS¿S CRITERIA FOR A SERIOUS INJURY. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE REMAINED UNRESOLVED AT THE TIME OF TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673506 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3530257

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR