BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 6176498 · Received December 15, 2016

    Report

    Report Number
    3008382007-2016-64393
    Event Type
    Injury
    Date Received
    December 15, 2016
    Report Date
    December 8, 2016
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    UDI-DI
    00353885008372
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENTS METER HAS 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, LIFESCAN CONDUCTED AN EVALUATION OF THE TEST STRIP LOT AND CONCLUDED THAT THIS LOT DID NOT BREACH THE THRESHOLDS SET FOR ESCALATION AND NO SYSTEMIC ISSUE WAS OBSERVED.

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) TO REPORT THAT HER ONETOUCH ULTRA2 METER READ INACCURATELY ERRATIC. THE COMPLAINT WAS CLASSIFIED BASED ON CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT ¿ONE WEEK¿ PRIOR TO CONTACTING LFS SHE OBTAINED RESULTS OF ¿200, 250, 125, 169, 171, 196 AND 250MG/DL¿ ON THE SUBJECT METER, PERFORMED WITHIN 20 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE IN RESULT EXCEEDS LFS CRITERIA FOR ACCURACY. THE PATIENT MANAGES HER DIABETES BY SELF-ADJUSTING HER INSULIN DOSES AND TOOK HER USUAL DOSE OF HUMALOG INSULIN IN RESPONSE TO THE ALLEGED ISSUE. THE PATIENT REPORTED THAT AN UNKNOWN TIME AFTER THE ALLEGED ISSUE OCCURRED SHE DEVELOPED SYMPTOMS OF ¿SHAKY AND SWEATY¿ HOWEVER DID NOT SPECIFY WHAT TREATMENT, IF ANY, WAS RECEIVED. DURING THE CALL THE CCA NOTED THAT THE METER WAS SET TO THE CORRECT UNIT OF MEASURE AND AN APPROVED SAMPLE SITE WAS USED. THE PATIENT HAD FOLLOWED THE CORRECT TESTING PROCEDURE AND THE TEST STRIPS HAD NOT EXPIRED ON BEEN STORED INCORRECTLY. THE PRODUCT WAS REPLACED AND REQUESTED BACK FOR EVALUATION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SIGNS AND/OR SYMPTOMS THAT MEET LFS¿ CRITERIA FOR A SERIOUS INJURY REPORTABLE ADVERSE EVENT AFTER THE ALLEGED PRODUCT ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    827402 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 4069591 00353885008372

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Life Threatening