BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 4584175 · Received March 10, 2015

    Report

    Report Number
    2939301-2015-09311
    Event Type
    Injury
    Date Received
    March 10, 2015
    Date of Event
    February 22, 2015
    Report Date
    February 25, 2015
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K073231
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE LAY USER/PATIENTS METER HAS BEEN RETURNED ON 3/12/2015 AND FURTHER EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 3/24/2015 WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE REPRODUCED. RETAIN TESTING COULD NOT BE PERFORMED AS THE TEST STRIP LOT NUMBER WAS NOT PROVIDED. 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 LAY USE/PATIENT CONTACTED LIFESCAN (LFS) AND ALLEGED THEIR ON TOUCH ULTRA LINK METER READ INACCURATE ERRATIC. THIS COMPLAINT WAS CLASSIFIED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ISSUE BEGAN ON (B)(6) 2015 AT 3.10 AM, WHEN THEY OBSERVED INACCURATE ERRATIC RESULTS OF ¿214, 171, 144 MG/DL¿ WITH THE SUBJECT METER WITHIN 20 MINUTES OF EACH OTHER. THE PATIENT MANAGES THEIR DIABETES WITH AN INSULIN PUMP. THE PATIENT CONFIRMED THEY DID NOT MAKE ANY CHANGES TO THEY DEVELOPED SYMPTOMS OF ¿SWEATY, BREATHING HEAVY¿ 1 HOUR 14 MINUTES AFTER THE PRODUCT ISSUE FIRST BEGAN. THE PATENT ALLEGED SELF-TREATMENT WITH MORE INSULIN ON (B)(6) 2015 AT 3.10AM. NO OTHER DEVICE WAS USED. AT THE TIME OF TROUBLE SHOOTING, THE CCA CONFIRMED THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE, THE TEST STRIP WERE NOT OPEN PAST THEIR DISCARD OR EXPIRY DATES AND THE TEST STRIPS WERE STORED CORRECTLY. THE CCA WAS UNABLE TO WALK THROUGH A RETEST AS THE PATIENT UNWILLING/UNABLE, HOWEVER WAS ABLE TO IDENTIFY THE PATIENT WAS USER THE CORRECT TESTING STEPS AND THE TEST STRIP VIAL WAS NOT BROKEN OR CRACKED. THE COMPLAINT HANDING DATA BASE DID NOT IDENTIFY THE TEST STRIPS AS COUNTERFEIT. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166245 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R