BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT PING METER

    MDR report key: 4112477 · Received September 24, 2014

    Report

    Report Number
    2939301-2014-25284
    Event Type
    Injury
    Date Received
    September 24, 2014
    Report Date
    September 15, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K082590
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 A FADED DISPLAY WITH THE ONETOUCH PING METER. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT ALLEGEDLY FIRST DISCOVERED THE ISSUE ON (B)(6) 2014 AT 2AM. THE PATIENT MANAGES HIS DIABETES WITH INSULIN PUMP THERAPY AND DID NOT MAKE ANY CHANGES TO HIS DIABETES REGIMEN AFTER THE ALLEGED DISPLAY ISSUE OCCURRED. ACCORDING TO THE CSR¿S DOCUMENTATION, TWO HOURS AFTER THE REPORTED ISSUE OCCURRED, THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS OF LIGHTHEADEDNESS AND UNSPECIFIED VISION PROBLEMS. THE PATIENT, HOWEVER, DENIED RECEIVING ANY FORM OF MEDICAL INTERVENTION AFTER THE PRODUCT ISSUE OCCURRED. AT THE TIME OF TROUBLESHOOTING, THE CSR VERIFIED THE PATIENT WAS NOT USING THE SUBJECT METER FOR THE FIRST TIME, THERE WAS NO MISUSE OF THE LFS PRODUCT, AND AFTER THE PRODUCT ISSUE OCCURRED THE PATIENT USED A BACKUP METER. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY SUFFERED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED PRODUCT ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593259 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3517699

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening