BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 4758082 · Received May 8, 2015

    Report

    Report Number
    2939301-2015-18332
    Event Type
    Injury
    Date Received
    May 8, 2015
    Date of Event
    April 27, 2015
    Report Date
    April 30, 2015
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    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

    ON (B)(6) 2015, THE PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRA 2 METER WAS READING INACCURATELY ERRATIC. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED INACCURACY BEGAN ON AROUND AT 06:30AM ET. THE PATIENT REPORTED OBTAINING INACCURATE ERRATIC BLOOD GLUCOSE RESULTS OF ¿312, 210, 166 AND 146MG/DL¿ ON THE SUBJECT METER, TESTED WITHIN LESS THAN 20 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS LIFESCAN¿S CRITERIA FOR PRECISION. IT IS UNCLEAR HOW THE PATIENT MANAGES HER DIABETES AND WHETHER SHE TOOK ANY ACTION TO HER USUAL DIABETES MANAGEMENT ROUTINE AS A RESULT OF THE ALLEGED PRODUCT ISSUE. THE PATIENT REPORTED THAT ¿TWO TO THREE DAYS¿ AFTER THE ALLEGED PRODUCT ISSUE SHE DEVELOPED SYMPTOMS OF ¿SHAKINESS, COLD SWEATING AND FAINTING¿. IT IS UNCLEAR WHAT TREATMENT THE PATIENT MAY HAVE RECEIVED. DURING TROUBLESHOOTING, IT WAS ESTABLISHED THAT THE PATIENT¿S TEST STRIPS HAD BEEN STORED CORRECTLY, THE TEST STRIP VIAL WAS NOT CRACKED OR BROKEN AND THE METER WAS SET TO THE CORRECT UNIT OF MEASURE. THE PATIENT HAD USED THE CORRECT TESTING STEPS AND APPROVED SAMPLE SITE. CCA NOTED THE PATIENT HAD NO CONTROL SOLUTION TO CARRY OUT A TEST. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY SUFFERED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED PRODUCT ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304971 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3768425

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Life Threatening