BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 3171414 · Received June 15, 2013

    Report

    Report Number
    3008382007-2013-17318
    Event Type
    Injury
    Date Received
    June 15, 2013
    Report Date
    May 31, 2013
    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
    HEALTH PROFESSIONAL

    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) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HIS ONETOUCH ULTRA2 METER WAS READING INACCURATELY LOW COMPARED TO A HOSPITAL METER AND WAS NOT POWERING ON WHEN HE TRIED TO TEST. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE FIRST OCCURRED DURING (B)(6) 2013, AT APPROXIMATELY 5PM. THE PATIENT REPORTED OBTAINING A READING OF ¿120MG/DL¿ ON THE LFS METER .THE PATIENT REPORTED USING ORAL MEDICATIONS (METFORMIN 1000MG TWICE A DAY) WITH DIET AND EXERCISE TO MANAGE HIS DIABETES. THE PATIENT REPORTED MAKING NO CHANGES TO HIS USUAL DIET, ACTIVITY LEVEL OR MEDICATIONS ON THE DAY OF THE ALLEGED ISSUE. THE PATIENT REPORTED ON AN UNKNOWN DATE AND TIME, HE DEVELOPED SYMPTOMS OF ¿DIZZINESS.¿ THE PATIENT REPORTED DURING (B)(6) 2013, AT APPROXIMATELY 5PM, HE WAS SEEN IN THE EMERGENCY ROOM (ER) AND READINGS THAT WERE APPROXIMATELY ¿500, 400, 300+MG/DL¿ WERE OBTAINED ON THE ER¿S METER AND THE PATIENT WAS TREATED WITH INSULIN. THE PATIENT REPORTED THE HOSPITAL METER READINGS AND THE LFS METER READINGS WERE MORE THAN 30 MINUTES FROM ONE ANOTHER. DURING THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THE METER WAS IN THE CORRECT UNIT OF MEASUREMENT AT THE TIME OF TESTING AND WAS USING AN APPROVED SAMPLE SITE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS DUE TO THE ALLEGED ISSUE HE REQUIRED MEDICAL TREATMENT FROM A HEALTHCARE PROFESSIONAL FOR SEVERELY HIGH BLOOD GLUCOSE. THERE IS NO INDICATION THAT THE SUBJECT METER MALFUNCTIONED SINCE THE ALLEGED TIME ELAPSED BETWEEN THE ALLEGED LFS METER AND THE HOSPITAL METER READINGS DID NOT MEET LFS' CRITERIA FOR ACCURACY REPORTING. THIS INCIDENT DESCRIPTION CONTAINS INFORMATION FROM RELATED (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272621 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| L| R