BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 1770629 · Received July 27, 2010

    Report

    Report Number
    2939301-2010-05925
    Event Type
    Malfunction
    Date Received
    July 27, 2010
    Report Date
    July 16, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 PCB CONTAMINATION . 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

    THE CUSTOMER REPORTED THAT SHE ACCIDENTALLY JUMPED INTO A POOL WHILE WEARING THE INSULIN PUMP AND THE DISPLAY WAS BLANK. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT WATER UNDERNEATH THE DISPLAY WAS OBSERVED. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    ON (B)(6), 2010, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING AN 'ERROR 1' ISSUE WITH A ONE TOUCH ULTRALINK METER. THE PATIENT INDICATED THAT THE ALLEGED ISSUE STARTED ON (B)(6), 2010, AT 2:00 PM. THIRTY MINUTES TO AN HOUR AFTER THE ALLEGED ISSUE BEGAN, THE PATIENT CLAIMED THAT SHE DEVELOPED A SYMPTOM OF THIRSTINESS. THE PATIENT DENIED THAT SHE RECEIVED ANY TREATMENT BECAUSE OF THE ALLEGED ISSUE. THE METER, TEST STRIPS, AND CONTROL SOLUTION WERE REPLACED. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE UNRESOLVED "ERROR 1" ISSUE OF THE METER. THERE IS NO EVIDENCE, HOWEVER, THAT THE ALLEGED ISSUE CONTRIBUTED TO THE PATIENT'S INJURY OR SYMPTOM OF THIRST WHICH CAN BE ASSOCIATED WITH HYPERGLYCEMIA. BASED ON THE RELATIVELY SHORT TIME FRAME AS TO WHEN THE ALLEGED ISSUE BEGAN AND THE ONSET OF THE SYMPTOM, THE PATIENT WAS MOST LIKELY IN A SUGGESTIVE STATE OF HYPERGLYCEMIA BEFORE THE ALLEGED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 2985225

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR