BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 4233904 · Received November 7, 2014

    Report

    Report Number
    2939301-2014-29778
    Event Type
    Injury
    Date Received
    November 7, 2014
    Report Date
    October 27, 2014
    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
    IL, US
    Reporter Occupation
    PATIENT

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT THEIR ONETOUCH ULTRA METER READ INACCURATELY HIGH WHEN COMPARED TO ANOTHER METER. THE CUSTOMER SERVICE REPRESENTATIVE (CSR) SPOKE WITH THE PATIENT ON (B)(6) 2014 WITH FOLLOW UP QUESTIONS FROM MEDICAL SURVEILLANCE AND OBTAINED THE FOLLOWING INFORMATION: THE PATIENT ALLEGED THAT THE PRODUCT ISSUE BEGAN AROUND 1-3PM ON THE AFTERNOON OF (B)(6) 2014. THE PATIENT REPORTED OBTAINING BLOOD GLUCOSE READINGS OF ¿194, 246, 119 AND 113MG/DL¿ ON THE SUBJECT METER AND ¿46 AND 50MG/DL¿ ON ANOTHER ONETOUCH ULTRA METER, PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS LIFESCAN¿S CRITERIA FOR ACCURACY. THE PATIENT MANAGES THEIR DIABETES WITH INSULIN WITH NO ADJUSTMENTS, SPECIFICALLY HUMALOG AND LANTUS. THE PATIENT REPORTED DEVELOPING SYMPTOMS OF ¿FEELING LOW, WEAK AND HUNGRY¿ BEFORE THE ALLEGED INACCURACY BEGAN. THE PATIENT REPORTED CONSUMING MORE FOOD/DRINK AS SELF-TREATMENT FOR THESE SYMPTOMS AND REPORTED FEELING BETTER 20-30 MINUTES LATER. PRIOR TO THE START OF THE ALLEGED INACCURACY THE PATIENT REPORTED LAST TESTING THEIR BLOOD GLUCOSE AT NOON AND STATED THAT THIS READING WAS HIGH BUT DID NOT PROVIDE THE EXACT READING. THE PATIENT REPORTED EATING SOME FOOD AND TAKING THEIR NORMAL MEDICATION IN RESPONSE TO THIS HIGH READING. AT THE TIME OF TROUBLESHOOTING THE CSR VERIFIED THAT THE UNIT OF MEASURE WAS SET CORRECTLY AND THAT THE TEST STRIPS WERE STORED CORRECTLY (PER OWNER¿S BOOKLET RECOMMENDATION). THE CSR NOTED THAT THE PATIENT DID NOT HAVE CONTROL SOLUTION AVAILABLE TO TEST THE SUBJECT METER. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT MAY HAVE DEVELOPED SYMPTOMS INDICATIVE OF A SERIOUS INJURY ON THE DAY THAT THE ALLEGED INACCURACY BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718015 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3613151

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R