BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 3765251 · Received April 22, 2014

    Report

    Report Number
    2939301-2014-09491
    Event Type
    Injury
    Date Received
    April 22, 2014
    Report Date
    April 16, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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) 2014, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HIS ONE TOUCH ULTRA 2 METER READ INACCURATELY LOW COMPARED TO HIS FEELINGS AND OR NORMAL RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED INACCURACY STARTED AT AN UNSPECIFIED TIME ON (B)(6) 2014. AT UNSPECIFIED DATES/TIMES, THE PATIENT OBTAINED BLOOD GLUCOSE RESULTS OF ¿137, 166, 91, 136, 160, 179, 130, 150, 152, 95 MG/DL¿ WITH THE SUBJECT METER. THE PATIENT MANAGES HIS DIABETES WITH INSULIN (UNKNOWN TYPE AND DOSAGE) AND STATED HE WOULD ¿EXERCISE¿ IN RESPONSE TO THE ALLEGED INACCURATE RESULT(S) OBTAINED WITH THE SUBJECT METER. THE PATIENT STATED, 4 TO 5 DAYS AFTER THE ALLEGED ISSUE OCCURRED, HE DEVELOPED SYMPTOMS OF ¿DIZZINESS.¿ AT AN UNSPECIFIED DATE/TIME, THE PATIENT WENT TO THE EMERGENCY ROOM (ER) WHERE HIS BLOOD GLUCOSE WAS TESTED AND OBTAINED RESULTS OF ¿349, 318 MG/DL¿ WITH AN ER/HOSPITAL METER. THE PATIENT WAS TREATED BY A HEALTH CARE PROFESSIONAL (HCP) WITH ¿IV FLUIDS.¿ DURING TROUBLESHOOTING, THE CUSTOMER CARE ADVOCATE (CCA) CONFIRMED THAT THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE SETTING. THE PATIENT DID NOT HAVE ANY CONTROL SOLUTION AT THE TIME TO TEST THE SUBJECT METER AND TEST STRIPS. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SIGNS/SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242398 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3595244

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Life Threatening| R