BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 3244043 · Received July 24, 2013

    Report

    Report Number
    3008382007-2013-20889
    Event Type
    Injury
    Date Received
    July 24, 2013
    Report Date
    July 15, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K062195
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ (08/22/2013). THE PATIENT¿S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 8/13/2013 AND 8/15/2013, RESPECTIVELY, WITH THE FOLLOWING FINDINGS:THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE CONFIRMED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2013 THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING SHE WAS UNABLE TO TEST BECAUSE HER ONETOUCH ULTRA METER WAS POWERING OFF DURING USE. THIS COMPLAINT WAS CLASSIFIED USING THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE FIRST OCCURRED ¿A FEW WEEKS¿ PRIOR TO CONTACTING LFS. THE PATIENT REPORTED USING ORAL MEDICATION WITH DIET AND EXERCISE TO MANAGE HER DIABETES. THE PATIENT REPORTED ON THE DAY OF THE ALLEGED ISSUE SHE MADE NO CHANGES TO HER USUAL DIET, ACTIVITY LEVEL OR MEDICATIONS. THE PATIENT REPORTED RIGHT AFTER THE ALLEGED ISSUE OCCURRED, SHE DEVELOPED SYMPTOMS OF FEELING ¿DIZZY AND FATIGUED¿. THE PATIENT REPORTED 3 WEEKS AFTER THE ALLEGED ISSUE BEGAN SHE WAS SEEN IN THE EMERGENCY ROOM AND HER BLOOD GLUCOSE WAS REPORTEDLY TESTED, SHE RECEIVED A ¿SHOT¿ AND SHE WAS TOLD TO GET A NEW METER. THE PATIENT REPORTED A BLOOD GLUCOSE READING OF ¿500MG/DL¿ WAS OBTAINED USING AN UNKNOWN SOURCE. IT IS UNCLEAR IF THE PATIENT WAS TREATED WITH INSULIN IN RESPONSE TO THE HIGH READING. AT THE TIME OF TROUBLESHOOTING, THE CCA WAS ABLE TO DETERMINE THERE WAS NO MISUSE OF THE PRODUCT AND THIS WAS NOT THE FIRST TIME THE METER HAD BEEN USED. THE PATIENT WAS EDUCATED REGARDING THE METER¿S AUTO SHUT OFF FUNCTION BUT THE ALLEGED ISSUE REMAINED UNRESOLVED. THE SUBJECT METER¿S BATTERY WAS FOUND TO BE IN GOOD CONDITION. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS, DUE TO THE ALLEGED ISSUE, SHE WAS UNABLE TO TEST AND THEREFORE REQUIRED TREATMENT FROM A HEALTH CARE PROFESSIONAL WHERE A SEVERELY HIGH BLOOD GLUCOSE READING WAS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346651 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| L| R