BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 4313829 · Received December 10, 2014

    Report

    Report Number
    2939301-2014-33732
    Event Type
    Injury
    Date Received
    December 10, 2014
    Report Date
    December 5, 2014
    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
    NY, 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 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 HIS ONETOUCH ULTRALINK METER READ INACCURATELY HIGH IN COMPARISON TO HIS FEELINGS OR NORMAL RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION AS THE PATIENT WAS NOT AVAILABLE FOR FOLLOW UP FROM MEDICAL SURVEILLANCE (MS). THE PATIENT REPORTED THAT ON (B)(6) 2014, AT 03:00AM, HE OBTAINED RESULTS OF ¿221, 238 AND 318MG/DL¿ ON THE SUBJECT METER. THE PATIENT DETAILED THAT HE MANAGES HIS DIABETES USING AN INSULIN PUMP AND DENIED MAKING ANY CHANGES TO HIS USUAL DIABETES MANAGEMENT ROUTINE IN RESPONSE TO THE ALLEGED ISSUE. THE PATIENT CLAIMED THAT ¿RIGHT AWAY¿ AFTER THE ALLEGED INACCURACY, HE DEVELOPED SYMPTOMS OF ¿FEELING HUNGRY AND SHAKING HANDS¿, HOWEVER DENIED RECEIVING ANY TREATMENT. DURING TROUBLESHOOTING THE CCA NOTED THAT THE METER WAS SET TO THE CORRECT UNIT OF MEASURE AND THE TEST STRIPS HAD NOT EXPIRED AND WERE IN GOOD CONDITION. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE, THE PATIENT CLAIMED THAT HE SUFFERED SYMPTOMS OF A SERIOUS BLOOD GLUCOSE EXCURSION AFTER THE ALLEGED INACCURACY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799788 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3480213

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Life Threatening