BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 3840038 · Received May 30, 2014

    Report

    Report Number
    2939301-2014-12831
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 22, 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
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ (07/05/2014).THE PATIENT¿S METER HAS BEEN RETURNED ON 6/19/2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 6/23/2014 WITH THE FOLLOWING FINDINGS:THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE REPRODUCED. 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) 2014, A REPORTER FOR THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THE PATIENT¿S ONETOUCH ULTRALINK METER READ INACCURATELY HIGH COMPARED TO ANOTHER DEVICE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ON THE EARLY MORNING OF (B)(6) 2014. IT WAS REPORTED THE PATIENT OBTAINED RESULTS OF ¿OVER 600 MG/DL¿ WITH THE SUBJECT METER AND ¿437 MG/DL¿ WITH ANOTHER DEVICE, PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 30% AND/OR <= 30 MG/DL. THE PATIENT MANAGES HIS DIABETES WITH METFORMIN PILLS, ACTOS PILLS, HUMALOG INSULIN AND BYDUREON INJECTIONS. ON THE EVENING OF (B)(6) 2014, THE PATIENT REPORTEDLY INCREASED HIS USUAL DOSE OF MEDICATIONS (TYPE/ AMOUNT NOT SPECIFIED). THE REPORTER CLAIMED THE PATIENT BECAME ¿UNCONSCIOUS.¿ THAT EVENING, THE PATIENT WAS BROUGHT TO THE EMERGENCY ROOM (ER) AND REPORTEDLY ADMINISTERED GLUCOSE, INTRAVENOUS (IV) FLUIDS AND A ¿DIRECT SHOT OF GLUCOSE¿ AS TREATMENT. THE PATIENT OBTAINED A RESULT OF ¿49 MG/DL¿ WITH ANOTHER DEVICE. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT AND AN APPROVED SAMPLE SITE WAS USED FOR TESTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED A SYMPTOM SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319097 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 2579699

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R