BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 4864568 · Received June 24, 2015

    Report

    Report Number
    2939301-2015-26102
    Event Type
    Injury
    Date Received
    June 24, 2015
    Date of Event
    June 14, 2015
    Report Date
    June 15, 2015
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT¿S METER AND TEST STRIPS HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS:THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE REPRODUCED. THE TEST STRIPS PASSED TESTING. 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.

    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) 2015, THE PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT THEIR ONE TOUCH ULTRA 2 METER WAS READING INACCURATELY ERRATIC. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED ISSUE OCCURRED ON ¿(B)(6) 2015, 10-11 PM¿ WHEN THE PATIENT OBTAINED BLOOD GLUCOSE RESULTS OF ¿357, 273, AND 290 MG/DL¿ ON THE SUBJECT METER, WHICH WERE TESTED LESS THAN 20 MINUTES APART. THE PATIENT MANAGES HER DIABETES WITH A COMBINATION OF MEDICATION, INCLUDING ¿METFORMIN, GLICIVIDE AND ONGLYZA¿ AND STATED THAT ON ¿(B)(6) 2015, AT APPROXIMATELY 10-11 PM¿ HE CONTINUED WITH HIS USUAL DOSE OF MEDICATION INCLUDING SLIDING SCALE. 2 HOURS AFTER THE ALLEGED INACCURACY THE PATIENT STATE THAT HE DEVELOPED SYMPTOMS OF ¿INCREASED BLOOD PRESSURE, CHEST PAIN, SWEATING THROUGH THE NIGHT AND BLURRED VISION IN THE MORNING¿. THE PATIENT DENIED RECEIVING MEDICAL INTERVENTION. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE CORRECT UNIT OF MEASURE AND APPROVED SAMPLE SITE WERE USED AT THE TIME OF TESTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY SUFFERED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED PRODUCT ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408046 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3787306

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR