BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRALINK METER

    MDR report key: 1727813 · Received December 21, 2009

    Report

    Report Number
    2939301-2009-07950
    Event Type
    Malfunction
    Date Received
    December 21, 2009
    Report Date
    December 7, 2009
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    LAY USER/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

    THE MEDICAL SURVEILLANCE SPECIALIST (MSS) CLASSIFIED THIS COMPLAINT BASED ON CUSTOMER SERVICE REP (CSR) DOCUMENTATION. THE REPORTER CONTACTED LIFESCAN (LFS) CUSTOMER SERVICE ON (B)(6) 2009, ALLEGING THAT HER DAUGHTER'S ONE TOUCH ULTRALINK STARTED TO GIVE ERRATIC METER READINGS "LAST TUESDAY". THE PT REPORTEDLY OBTAINED "130, 242, 494, 271, AND 189 MG/DL" WITHIN A 20 MINUTE TIME PERIOD: THE SPECIFIC DATES/TIMES OF EACH RESULT WERE NOT NOTED. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE EXCEEDS THE EXPECTED VALUE OF <=20%. THE REPORTER INDICATED THAT THE PT DEVELOPED SYMPTOMS OF LIGHTHEADEDNESS, NAUSEA, HEADACHE, AND SHAKING AT THE TIME OF CONCERN; HOWEVER, SHE WAS UNABLE TO REPORT IF THE SYMPTOMS STARTED BEFORE OR AFTER THE ALLEGED INACCURACY ISSUE. IT WAS NOTED THAT THE PT WAS RECEIVING PHONE ADVISE FROM A HEALTH CARE PROFESSIONAL FROM DEC 3, 2009: THE PT WAS ADVISED TO INCREASE HER INSULIN DOSAGES. THE REPORTER ALSO PROVIDED BLOOD GLUCOSE RESULTS THAT WERE OBTAINED ON (B)(6) 2009, FROM THE PT'S SCHOOL METER: THE RESULTS WERE "80, 74, 184, 219, AND 230 MG/DL" FROM NOON-4:30PM. NO OTHER FORMS OF TREATMENT WERE REPORTED. ACCORDING TO THE TROUBLESHOOTING PERFORMED BY THE CUSTOMER SERVICE, THE CORRECT TESTING STEPS WERE TAKEN. THE CSR ATTEMPTED TO WALK THE REPORTER THROUGH A CONTROL SOLUTION TEST, BUT SHE DID NOT HAVE ANY CONTROL SOLUTION. THERE IS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THE PT'S SYMPTOMS AND TREATMENT (PHONE ADVICE) CORRELATED WITH THE ALLEGED INACCURATE METER READINGS. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED METER READINGS DID NOT MEET LIFESCAN'S PRECISION CRITERIA. REPLACEMENT PRODUCTS WERE SENT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2864877

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR