BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 3893444 · Received June 25, 2014

    Report

    Report Number
    2939301-2014-15424
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 18, 2014
    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
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HIS ONE ULTRA 2 METER READ INACCURATELY HIGH/ERRATIC COMPARED TO HIS FEELINGS AND OR NORMAL RESULTS AND WHEN PERFORMING CONSECUTIVE BLOOD GLUCOSE TESTS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED INACCURACY BEGAN ON (B)(6) 2014 AT 6:00 A. M. AT AN UNSPECIFIED DATE/TIME, THE PATIENT OBTAINED BLOOD GLUCOSE READINGS OF ¿87, 141 MG/DL¿ WITH THE SUBJECT METER, PERFORMED WITHIN 20 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY THE CALCULATED DIFFERENCE BETWEEN THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF LESS THAN OR EQUAL TO 20%. THE PATIENT MANAGES HIS DIABETES WITH ¿LIPOSITE¿ AND INSULIN (UNKNOWN TYPE AND DOSAGE). IT IS NOT KNOWN IF THE PATIENT MADE ANY CHANGES TO HIS USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ALLEGED INACCURATE READING(S) OBTAINED WITH THE SUBJECT METER. THE PATIENT STATED AT 6:00 P. M. HE DEVELOPED SYMPTOMS OF ¿NUMB, WEAK, AND SWEATY¿. THE PATIENT IMMEDIATELY SELF-TREATED WITH FOOD AND/OR DRINK IN RESPONSE TO THE SYMPTOMS. DURING TROUBLESHOOTING, THE 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
    371912 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3527022

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Life Threatening| R