BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 1904702 · Received November 22, 2010

    Report

    Report Number
    2939301-2010-10112
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Report Date
    November 4, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    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; 510(K)# IS K082590.

    Additional Manufacturer Narrative · 1

    FOLLOW UP # 1/SUPPLEMENTAL REPORT TEXT-11/19/2010. THE LAY USER/PATIENT'S PRODUCT(S) HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE FAILED TESTING. THE METER WAS FOUND TO HAVE CRACKED/BROKEN DISPLAY. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A SECOND FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    Description of Event or Problem · 1

    AN ATTORNEY ALLEGES THAT A PATIENT UNDERWENT POSTERIOR SPINAL FUSION, AFTER WHICH SHE "EXPERIENCED SIGNIFICANT PAIN AND OTHER ADVERSE SYMPTOMS." IT IS REPORTED THAT SEVEN MONTHS POSTOPERATIVELY, THE PATIENT UNDERWENT ADDITIONAL SURGERY THAT "REVEALED CATASTROPHIC FAILURE" OF THE SYSTEM, AND FOUR DAYS LATER, "A SUBSTANTIAL PORTION OF THE INSTRUMENTATION" WAS REPLACED. IT IS ALLEGED THAT "THE HARDENED SURFACES OF CERTAIN PIECES WERE COMPROMISED AND WEAKENED WHEN THE SCREWS USED TO HOLD THE PIECES WERE TIGHTENED TO THE RECOMMENDED LEVELS." NO DETAILS WERE PROVIDED AND NO OTHER INFORMATION WAS GIVEN.

    Description of Event or Problem · 1

    THERE IS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE CRACKED DISPLAY WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3041173

    Patients

    Seq Age Sex Outcome Treatment
    1