BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 4647162 · Received April 1, 2015

    Report

    Report Number
    2939301-2015-12947
    Event Type
    Injury
    Date Received
    April 1, 2015
    Report Date
    March 26, 2015
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ THE PATIENT¿S METER HAS BEEN RETURNED ON 4/24/2015 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 5/1/2015 WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE REPRODUCED. THE RETAIN TEST STRIPS ALSO PASSED ALL TESTING. A DHR (DEVICE HISTORY RECORD) WAS COMPLETED ON 05/05/2015 FOR THIS PRODUCT AND NO DEVIATIONS, NON-CONFORMANCES, OR REWORKS WERE OBSERVED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2015, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS), ALLEGING THAT HIS ONETOUCH ULTRA2 METER READ INACCURATELY ERRATIC. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ISSUE WITH THE METER STARTED ¿A WEEK AGO¿. THE PATIENT REPORTED OBTAINING READINGS OF ¿260, 212, AND 180 MG/DL¿ ON THE SUBJECT METER, TESTED LESS THAN 20 MINUTES APART. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS LIFESCAN¿S CRITERIA FOR ACCURACY. THE PATIENT MANAGES HIS DIABETES WITH ORAL MEDICATION, DIET AND EXERCISE AND TOOK NO ACTION TO HIS USUAL DIABETES MANAGEMENT REGIMEN ROUTINE AS A RESULT OF THE PRODUCT ISSUE. THE PATIENT STATED THAT AN UNSPECIFIED TIME AFTER THE ALLEGED PRODUCT ISSUE THAT HE DEVELOPED SYMPTOMS OF ¿DIZZY AND SHAKING¿. THE PATIENT DENIED RECEIVING ANY TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE CORRECT UNIT OF MEASURE AND APPROVED SAMPLE SITE WERE USED AT THE TIME OF TESTING. THE CORRECT TEST STRIPS AND TESTING TECHNIQUE WAS USED. THE TEST STRIP VIAL WAS INTACT AND THE PATIENT DID NOT HAVE CONTROL SOLUTION. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY SUFFERED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED PRODUCT ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213345 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3778229

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Life Threatening