BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 3132633 · Received May 29, 2013

    Report

    Report Number
    3008382007-2013-13386
    Event Type
    Injury
    Date Received
    May 29, 2013
    Report Date
    May 11, 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
    PA, 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 ¿ ((B)(4)). 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 TEST STRIPS WERE ALSO TESTED AND THE PRIMARY COMPLAINT WAS NOT 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 HIS ONETOUCH ULTRA2 METER WAS DISPLAYING INACCURATELY HIGH READINGS COMPARED TO AN EMERGENCY MEDICAL SERVICES (EMS) METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE FIRST OCCURRED ON (B)(6) 2013 AT 11 AM. THE PATIENT REPORTED OBTAINING AN UNKNOWN READING ON THE LFS METER COMPARED TO ¿24 MG/DL¿ ON AN EMS METER. IT IS UNCLEAR IF THE PATIENT MADE ANY CHANGES TO HIS USUAL DIET, ACTIVITY LEVEL, MEDICATIONS ON THE DAY OF THE ALLEGED ISSUE. THE PATIENT DENIED DEVELOPING ANY SYMPTOMS ON THE DAY OF THE ALLEGED ISSUE. HOWEVER ON (B)(6) 2013 THE PATIENT WAS DEFIBRILLATED BY EMS DUE TO AN EXTREMELY LOW PULSE. IT IS UNKNOWN IF THE PATIENT RECEIVED ANY TREATMENT FOR THE SEVERELY LOW BLOOD GLUCOSE READING. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THE PATIENT WAS USING THE CORRECT TESTING STEPS AND AN APPROVED SAMPLE SITE FOR TESTING. THE PATIENT¿S TEST STRIPS AND TEST STRIPS VIAL WERE IN GOOD CONDITION. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS A SEVERELY LOW BLOOD GLUCOSE READING WAS OBTAINED BY EMS ON THE DAY OF THE ALLEGED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234598 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3367123

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| L| R