BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 1812679 · Received August 24, 2010

    Report

    Report Number
    2939301-2010-07092
    Event Type
    Malfunction
    Date Received
    August 24, 2010
    Report Date
    August 16, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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), 2010, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE ONETOUCH PING METER HAS BLACK MARKS IN THE DISPLAY. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT ALLEGED THAT THE ISSUE BEGAN ON (B)(6), 2010 AT 2PM. IT IS NOT KNOWN WHAT MEDICATION, IF ANY, THE PATIENT TAKES TO MANAGE HER DIABETES. IT IS ALSO NOT KNOWN WHAT ACTION, IF ANY, THE PATIENT TOOK REGARDING HER DIABETES MANAGEMENT AS A RESULT OF THE ALLEGED ISSUE. ACCORDING TO THE CSR DOCUMENTATION, AT AN UNSPECIFIED TIME PRIOR TO THE ALLEGED ISSUE, THE PATIENT EXPERIENCED SYMPTOMS OF DIZZINESS AND FELT LIGHT HEADED. THE PATIENT, HOWEVER, DENIED RECEIVING TREATMENT FOLLOWING THE ALLEGED ISSUE. AT THE TIME OF TROUBLESHOOTING, THE CSR VERIFIED THAT THERE WAS NO MISUSE WITH THE SUBJECT METER. A REPLACEMENT METER WAS SENT TO THE PATIENT. 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. THERE WAS NO INDICATION THAT THE PATIENT'S SYMPTOMS DETERIORATED SINCE THE PATIENT DID NOT RECEIVE ANY FORM OF MEDICAL INTERVENTION AFTER THE PRODUCT ISSUE OCCURRED. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE REMAINS UNRESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 2990415

    Patients

    Seq Age Sex Outcome Treatment
    1