BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRASMART METER

    MDR report key: 4134025 · Received October 2, 2014

    Report

    Report Number
    2939301-2014-26156
    Event Type
    Injury
    Date Received
    October 2, 2014
    Date of Event
    September 29, 2014
    Report Date
    September 30, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 ¿ (11/06/2014). THE PATIENT¿S METER HAS BEEN RETURNED ON 10/22/2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 10/27/2014 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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE PATIENT CONTACTED LIFESCAN (LFS) USA ALLEGING THAT HER ONETOUCH ULTRA SMART METER READ INACCURATELY HIGH. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE CCA WAS ADVISED BY THE PATIENT THAT ALLEGED INACCURACY BEGAN ON (B)(6) 2014 AT BETWEEN 1 AND 2PM. THE PATIENT REPORTED OBTAINING AN INACCURATE HIGH RESULT OF ¿77MG/DL¿ ON THE SUBJECT METER COMPARED TO ¿22MG/DL¿ ON A PARAMEDIC¿S METER, TESTED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS LIFESCAN¿S CRITERIA FOR ACCURACY. THE PATIENT CURRENTLY MANAGES HER DIABETES BY SELF-ADJUSTING INSULIN DOSES AND DENIES TAKING ANY ACTION IN RESPONSE TO HER REGULAR DIABETES MANAGEMENT ROUTINE PRIOR TO THE ALLEGED PRODUCT ISSUE. APPROXIMATELY AN HOUR AFTER THE METER ISSUE, THE PATIENT STATED THAT SHE EXPERIENCED SYMPTOMS OF ¿HYPOGLYCEMIA, SHAKING, SWEATING AND DIZZINESS¿. THE PATIENT STATED SHE WAS TREATED WITH IV FLUIDS IN AN EMERGENCY ROOM (ER) BY A HEALTH CARE PROFESSIONAL (HCP). AT THE TIME OF TROUBLESHOOTING, THE CCA DETERMINED THAT THE CORRECT UNIT OF MEASURE AND CORRECT TESTING PROCEDURE WERE USED AT THE TIME OF TESTING. REPLACEMENT PRODUCTS HAVE BEEN SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED; THIS COMPLAINT IS BEING REPORTED BASED ON THE FOLLOWING CONCLUSIONS: BASED ON THE FOLLOWING INFORMATION PROVIDED, THE PATIENT DID SUFFER SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED PRODUCT ISSUE BEGAN. THE ALLEGED PRODUCT ISSUE WITH THE LFS DEVICE COULD NOT BE RULED OUT AS A CAUSE OR CONTRIBUTOR TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617043 OT ULTRASMART METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3672416

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R