BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 3865068 · Received June 11, 2014

    Report

    Report Number
    2939301-2014-14071
    Event Type
    Injury
    Date Received
    June 11, 2014
    Report Date
    June 6, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K061118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ (07/08/2014). THE PATIENT¿S METER HAS BEEN RETURNED ON 6/20/2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 6/25/2014 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, THE LAY-USER/REPORTER CONTACTED LIFESCAN (LFS) USA ON BEHALF OF THE PATIENT, ALLEGING THAT THE ONETOUCH ULTRAMINI METER IS GIVING INACCURATE HIGH READINGS OF ¿132 AND 118 MG/DL¿ COMPARED TO ANOTHER METER READING OF ¿118 MG/DL.¿ THIS COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. ON (B)(6) 2014, AT 10 AM, THE PATIENT REPORTEDLY TOOK 0.12 UNIT OF VICTOZA AND MANAGED HIS DIABETES WITH INSULIN BASED ON THE ALLEGED READINGS OF ¿132 AND 118 MG/DL.¿ SUBSEQUENTLY, 1.5 HOURS LATER, THE PATIENT ALLEGEDLY DEVELOPED SYMPTOMS DESCRIBED AS ¿SHAKY, DIZZY, AND SWEATY.¿ DURING TROUBLESHOOTING, THE REPORTER CONFIRMED THE READINGS WERE TAKEN WITHIN 30 MINUTES OF EACH OTHER. THE UNIT OF MEASUREMENT WAS SET CORRECTLY. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS WERE WITHIN THE EXPECTED VALUE OF <= 30% AND/OR <= 30 MG/DL. THE LFS PRODUCTS WERE REPLACED AND REQUESTED BACK FOR INVESTIGATION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED SHE DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AFTER SHE TOOK INSULIN BASED ON THE ALLEGED INACCURATE HIGH METER READINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345287 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3545750

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening