BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 3243671 · Received July 23, 2013

    Report

    Report Number
    3008382007-2013-20815
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    July 11, 2013
    Report Date
    July 11, 2013
    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
    EI
    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 ¿ (11/27/2013). THE PATIENT¿S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 11/19/2013 AND 11/21/2013, RESPECTIVELY, WITH THE FOLLOWING FINDINGS:ANALYSIS WAS NOT POSSIBLE FOR THE METER INVOLVED WITH THIS COMPLAINT DUE TO THE NOTED SECONDARY ISSUE OF SPC PIN 1 BEING CONTAMINATED WITH DRY BLOOD AND PIN 2 WAS LIFTED HIGH. A DHR (DEVICE HISTORY RECORD) WAS COMPLETED ON 08/27/2013 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) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THAT HER ONETOUCH ULTRA2 METER CONTINUOUSLY DISPLAYED AN ¿ERROR 5¿ MESSAGE INSTEAD OF A RESULT. PER THE OWNER¿S BOOKLET, THIS ERROR APPEARS WHEN THE METER HAS DETECTED A PROBLEM WITH THE TEST STRIP. POSSIBLE CAUSED ARE TEST STRIP DAMAGE OR AN INCOMPLETELY FILLED CONFIRMATION WINDOW. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT REPORTED THAT THE ERROR MESSAGE BEGAN TO APPEAR ON (B)(6) 2013, AT 6:00PM. THE PATIENT MANAGES HER DIABETES WITH INSULIN. DUE TO THE ERROR MESSAGE APPEARING, THE PATIENT CLAIMED SHE TOOK A DECREASED AMOUNT OF NOVORAPID INSULIN. THE PATIENT STATED SHE ADMINISTERED 40 UNITS INSTEAD OF HER USUAL 50 UNITS. APPROXIMATELY 18 HOURS AFTER THE ERROR MESSAGE STARTED TO APPEAR, THE PATIENT CLAIMED SHE DEVELOPED SYMPTOMS OF ¿THIRST AND TIREDNESS¿. IT IS NOT KNOWN WHAT TREATMENT, IF ANY, THE PATIENT RECEIVED IN RESPONSE TO THE SYMPTOMS. AT THE TIME OF TROUBLESHOOTING, THE PATIENT REPORTED THAT SHE OBTAINED THE ERROR MESSAGE WITH MULTIPLE STRIP CONTAINERS. THE PATIENT CONFIRMED THE STRIPS APPEARED IN CONDITION. THE PATIENT ALSO CONFIRMED THAT THE BLOOD SAMPLE WAS DRAWN INTO THE STRIPS CONFIRMATION WINDOW. THE ALLEGED ERROR MESSAGE REMAINED UNRESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SIGNS/SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED ERROR MESSAGE APPEARED WITH THE LFS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344099 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3405646

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Life Threatening