BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 4233958 · Received November 7, 2014

    Report

    Report Number
    2939301-2014-29808
    Event Type
    Malfunction
    Date Received
    November 7, 2014
    Report Date
    October 28, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K073231
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 HER ONETOUCH ULTRALINK METER WAS READING INACCURATELY LOW COMPARED TO HER FEELINGS AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED INACCURACY BEGAN ON (B)(6) 2014 AT APPROXIMATELY 1PM WHEN A READING OF 110MG/DL WAS OBTAINED USING THE SUBJECT DEVICE. THE PATIENT STATED THAT SHE MANAGES HER DIABETES USING INJECTABLE DIABETES MEDICATIONS (NOT INSULIN, BRAND NOT SPECIFIED). IN RESPONSE TO THE READING OBTAINED, THE PATIENT REPORTEDLY CONSUMED ADDITIONAL FOOD AND/OR DRINK. APPROXIMATELY 2-3 HOURS AFTER THE ALLEGED ISSUE OCCURRED, THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS OF ¿SHAKY, CLAMMY AND NAUSEOUS¿. THE PATIENT CLAIMED SHE TREATED HERSELF WITH SUGAR CUBES IN RESPONSE TO THE SYMPTOMS. AT THE TIME OF TROUBLESHOOTING, THE CSR DETERMINED THAT THE UNIT OF MEASURE WAS SET CORRECTLY AND THE TEST STRIPS HAD NOT EXPIRED. THE CSR WALKED THE PATIENT THROUGH A RE-TEST AND THE RESULT WAS NOT IN RANGE. REPLACEMENT PRODUCTS HAVE BEEN SENT TO THE PATIENT. THERE IS NO INDICATION THAT THE SUBJECT METER CAUSED OR CONTRIBUTED TO A SERIOUS INJURY AS THE PATIENT¿S SYMPTOMS AND TREATMENT CORRELATE WITH THE REPORTED METER ISSUE. HOWEVER THIS COMPLAINT IS BEING REPORTED AS A MALFUNCTION BECAUSE THE CONTROL SOLUTION TEST RESULT WAS NOT IN RANGE AT THE TIME OF TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716998 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3546915

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR