BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRASMART METER

    MDR report key: 4469543 · Received January 30, 2015

    Report

    Report Number
    2939301-2015-03623
    Event Type
    Injury
    Date Received
    January 30, 2015
    Report Date
    January 21, 2015
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K021819
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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, LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) CANADA AND ALLEGED THEIR ONE TOUCH ULTRA 2 METER READ INACCURATELY HIGH COMPARED TO ANOTHER METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ISSUE BEGAN A YEAR AGO, THEY OBTAINED INACCURATE HIGH RESULTS OF ¿205, 171,91, 71,146, 110, 296 MG/DL¿ WITH THE SUBJECT METER AND AN UNKNOWN RESULTS WITH ANOTHER DEVICE (OT ULTRA MINI), PERFORMED WITHIN 30 MINUTES. THE PATIENT MANAGES HER DIABETES WITH INSULIN (SELF-ADJUSTER). THE PATIENT CLAIMS SHE DEVELOPED SYMPTOMS, 1-2 DAYS BEFORE THE PRODUCT ISSUE BEGAN; HOWEVER WAS UNABLE TO RECALL WHAT SYMPTOMS DEVELOPED. THE PATIENT ALLEGED ON AN UNKNOWN DATE AND TIME BEING TREATED AT THE EMERGENCY ROOM(ER) WITH INSULIN (HUMALOG-SLIDING SCALE). ANOTHER DEVICE WAS USED TO TEST THE PATIENT BLOOD GLUCOSE; THE PATIENT DOES NOT RECALL THE RESULT. AT THE TIME OF TROUBLE SHOOTING, THE CCA CONFIRMED THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE AND THE CORRECT APPROVED SAMPLE WAS USED. THE TEST STRIPS WERE NOT OPEN PAST THEIR DISCARD OR EXPIRY DATES AND THE TEST STRIPS WERE STORED CORRECTLY. THE CCA WAS UNABLE TO WALK THROUGH A RETEST WITH THE PATIENT, THE RESULT WAS WITHIN RANGE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THERE IS NO EVIDENCE OF A METER MALFUNCTION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY WAS TREATED WITH INSULIN BY THE EMERGENCY SERVICES FOR A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71369 OT ULTRASMART METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3708326

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Life Threatening| R