BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT PING METER

    MDR report key: 2182492 · Received July 28, 2011

    Report

    Report Number
    2939301-2011-06526
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 5, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER INVOLVED IN THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: THE RETURNED METER FAILED TESTING. THERE WAS CONTAMINATION FOUND ON THE METER'S PC BOARD.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH PING METER DOES NOT TURN ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE CCA WAS ADVISED BY THE PATIENT THE ALLEGED ISSUE OCCURRED ON (B)(6) 2011 AT 6:00AM. IT IS NOT KNOWN WHAT SPECIFIC DIABETES MEDICATION THE PATIENT TAKES TO MANAGE HIS DIABETES BUT THE PATIENT DID STATE THAT HE TOOK 10 UNITS OF HUMALOG IMMEDIATELY AFTER THE REPORTED ISSUE BEGAN. TWO HOURS AFTER THE ALLEGED PRODUCT ISSUE OCCURRED, THE PATIENT CLAIMED TO HAVE DEVELOPED SYMPTOMS OF BEING "THIRSTY AND EDGY". IT IS NOT KNOWN IF THE PATIENT RECEIVED ANY MEDICAL TREATMENT IN RESPONSE TO THE SYMPTOMS. AT THE TIME OF TROUBLESHOOTING, THE CCA DETERMINED THAT THE CORRECT TYPE OF STRIPS WAS BEING USED AND THAT THE BATTERY DID NOT REQUIRE REPLACEMENT. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3117119

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening