BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 6921477 · Received October 6, 2017

    Report

    Report Number
    3008382007-2017-22731
    Event Type
    Injury
    Date Received
    October 6, 2017
    Report Date
    September 28, 2017
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    UDI-DI
    00353885008372
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENTS 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 CONFIRMED. IN ADDITION, A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE SUBJECT METER LOT. THE REVIEW DID NOT IDENTIFY ANYTHING THAT COULD ADVERSELY IMPACT PRODUCT PERFORMANCE OR FUNCTION. ANALYSIS WAS NOT POSSIBLE FOR THE RETURNED TEST STRIPS DUE TO UNKNOWN STORAGE AND HANDLING PREVENTING THE ALLEGATION BEING PHYSICALLY INVESTIGATED. 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) 2017, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA ALLEGING THAT THEIR ONETOUCH ULTRA2 METER READ INACCURATELY HIGH COMPARED TO ANOTHER METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED INACCURACY OCCURRED AT 3AM ON (B)(6) 2017. AT THIS TIME, THE PATIENT OBTAINED A BLOOD GLUCOSE RESULT OF ¿236MG/DL¿ WITH THE SUBJECT METER AND A RESULT OF ¿179MG/DL¿ ON ANOTHER DEVICE WITHIN 30 MINUTES OF ONE ANOTHER. THE PATIENT MANAGES THEIR DIABETES BY TAKING 20 UNITS OF NOVOLOG INSULIN PER DAY AND STATED THAT THEY DECREASED THIS USUAL DOSAGE TO 15 UNITS IN RESPONSE TO THE ALLEGED PRODUCT ISSUE. THE PATIENT REPORTED THAT 3-4 HOURS AFTER THE ALLEGED PRODUCT ISSUE OCCURRED THEY DEVELOPED SYMPTOMS OF ¿CHILLS AND SHAKES¿; HOWEVER, DID NOT REQUIRE ANY FORM OF TREATMENT AS A RESULT OF THESE SYMPTOMS. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER AND AN APPROVED SAMPLE SITE WAS BEING USED TO OBTAIN THE BLOOD GLUCOSE RESULTS. THE PATIENT DID NOT HAVE CONTROL SOLUTION AVAILABLE TO WALK THROUGH A CONTROL SOLUTION TEST WITH THE CCA. THE PATIENT¿S PRODUCTS WERE REPLACED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY ADVERSE EVENT AFTER ALLEGEDLY OBTAINING INACCURATELY HIGH RESULTS WITH THE SUBJECT METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702115 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 00353885008372

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Life Threatening