BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 3141827 · Received June 3, 2013

    Report

    Report Number
    3008382007-2013-14628
    Event Type
    Injury
    Date Received
    June 3, 2013
    Report Date
    May 9, 2013
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ ((B)(4) 2013). THE PATIENT¿S METER AND TEST STRIPS HAVE BEEN RETURNED ON (B)(4) 2013 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2013, RESPECTIVELY, WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE CONFIRMED. THE TEST STRIPS WERE ALSO TESTED AND THE PRIMARY COMPLAINT WAS NOT CONFIRMED. THE RETAIN TEST STRIPS PASSED THE PERFORMANCE TESTING WITH BLOOD. A DHR (DEVICE HISTORY RECORD) WAS COMPLETED ON (B)(4) 2013 FOR THIS PRODUCT AND NO DEVIATIONS, NON-CONFORMANCES, OR REWORKS WERE OBSERVED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    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 READ INACCURATELY ERRATIC. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. IT IS NOT SPECIFIED WHEN THE ALLEGED ISSUE BEGAN. THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF ¿182 AND 52 MG/DL¿ WITH THE SUBJECT METER, PERFORMED GREATER THAN 20 MINUTES OF EACH OTHER. THE PATIENT MANAGES HIS DIABETES WITH GLYBURIDE PILLS (5 MG). THE PATIENT REPORTEDLY CONTINUED TO ADMINISTER HIS USUAL DOSE OF MEDICATIONS. NO SYMPTOMS WERE SPECIFIED; HOWEVER, A COUPLE MONTHS PRIOR TO CONTACTING LFS, THE PATIENT ALLEGED EMERGENCY MEDICAL SERVICES (EMS) WAS CONTACTED. AT THAT TIME, THE PATIENT OBTAINED A BLOOD GLUCOSE RESULT OF ¿48 MG/DL¿ WITH THE EMS METER. THE PATIENT WAS REPORTEDLY TREATED WITH GLUCOSE TABLETS/ GLUCOSE GEL AS TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT AND AN APPROVED SAMPLE SITE WAS USED FOR TESTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT MAY HAVE RECEIVED MEDICAL INTERVENTION FROM A HEALTH CARE PROFESSIONAL (HCP) AFTER THE REPORTED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243129 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3390608

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Life Threatening| R