BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1071015 · Received July 2, 2008

    Report

    Report Number
    2939301-2008-01310
    Event Type
    Malfunction
    Date Received
    July 2, 2008
    Date of Event
    June 11, 2008
    Report Date
    June 12, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVAL, BUT HAS NOT YET RECEIVED THEM. IF EITHER THE METER OR STRIPS ARE RETURNED, LIFESCAN WILL EVALUATE IT/THEM AND, IF EITHER THE METER OR STRIPS DO NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IN 2008, A REPORTER/LAYPERSON (DAUGHTER) SPOKE WITH A CUSTOMER CARE ADVOCATE, CCA, REGARDING THE PT/LAYPERSON'S ONE TOUCH ULTRA METER. THE REPORTER ALLEGED THAT THE PT'S BLOOD GLUCOSE RESULTS WHEN TESTED WERE INACCURATELY ERRATIC IN 2008, AND ABOUT TWO DAYS LATER, THE PT RECEIVED TREATMENT FROM AN EMERGENCY MEDICAL TEAM, EMT. THIS SENIOR MEDICAL AFFAIRS SPECIALIST IS CLASSIFYING THE COMPLAINT BASED UPON THE INFO GIVEN TO THE CCA. SINCE THERE IS NO ANSWER AT THE NUMBER PROVIDED, A LETTER WILL BE SENT, RESULTS ARE IN MG/DL. BECAUSE OF PERCEIVED VARIANCES (RESULTS NOT PROVIDED) THAT BEGAN IN 2008, THE PT REPORTEDLY TESTED OR WAS TESTED EVERY COUPLE OF HOURS. TYPICALLY THE SCHEDULE IS THREE TIMES A DAY. THE REPORTER ALLEGED THAT AT ABOUT THREE DAYS LATER, THE PT OBTAINED RESULTS OF AROUND 157 AND THEN 99 ONE HOUR LATER WITH NO EXERCISE, MEDICATION OR FOOD IN BETWEEN. RESULTS OF 151 AND 91 WERE FOUND IN METER'S MEMORY. THE PT'S UNKNOWN INSULIN REGIME DOES NOT VARY BASED UPON METER RESULTS. ABOUT TWO DAYS LATER AT 11 P.M., EMT WAS REPORTEDLY CALLED. THE REPORTER DID NOT INDICATE WHY, OR WHETHER THE PT WAS DISPLAYING SYMPTOMS OF ANY KIND. THE REPORTER STATED, "HER METER WAS REALLY LOW." THE REPORTER DID NOT SPECIFY WHOSE METER SHE WAS REFERRING TO, THE PT'S OR THE EMT'S. EMT REPORTEDLY GAVE THE PT ORAL GLUCOSE, AND OBTAINED "126" ON THEIR OWN METER. IT IS NOT CLEAR IF THE "126" WAS OBTAINED BEFORE OR AFTER THE ORAL GLUCOSE WAS ADMINISTERED. THE CCA DISCOVERED THAT THE PT'S METER WAS CODED INCORRECTLY; METER CODE 43 AND TEST STRIPS CODE 1. DUE TO THE WIDE DISCREPANCY, BLOOD GLUCOSE RESULTS WOULD BE INACCURATE. THE CCA WAS UNABLE TO PERFORM A CONTROL SOLUTION TEST BECAUSE THE PT HAD NON-LIFESCAN CONTROL. ALTHOUGH THE REPORTER DID NOT ALLEGE HARM DUE TO THE PRODUCT AND ALTHOUGH THERE IS NO EVIDENCE THE PRODUCT MALFUNCTIONED, THE COMPLAINT IS CLASSIFIED AS AN ADVERSE EVENT DUE TO TREATMENT GIVEN BY A HEALTHCARE PROFESSIONAL, AFTER THE REPORTED ISSUE, POSSIBLY BECAUSE THE PT OR A FAMILY MEMBER HAD MISCODED THE METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2772555

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Life Threatening