BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® INSIGHT METER

    MDR report key: 5236247 · Received November 19, 2015

    Report

    Report Number
    3011393376-2015-05154
    Event Type
    Injury
    Date Received
    November 19, 2015
    Date of Event
    October 29, 2015
    Report Date
    August 5, 2025
    Manufacturer
    SANMINA CORPORATION
    Product Code
    NBW
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE THIS PRODUCT IS NOT SOLD IN THE UNITED STATES, IT IS LIKE OR SIMILAR TO A PRODUCT MARKETED IN THE UNITED STATES. THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    REPORTER STATED THE CUSTOMER EXPERIENCED SEVERE HYPOGLYCEMIA THAT REQUIRED TREATMENT DUE TO INACCURATE BOLUS ADVICE FROM THE BLOOD GLUCOSE MONITOR. ON (B)(6) 2015, SHE RECEIVED A RESULT OF 14.2 MMOL/L AND DELIVERED THE RECOMMENDED BOLUS OF 13.7 UNITS. APPROXIMATELY 2 HOURS LATER, SHE RECEIVED A RESULT OF 2.6 MMOL/L AND THEN COLLAPSED IN A GROCERY STORE. AN AMBULANCE WAS CALLED, AND THE PARAMEDICS TREATED THE CUSTOMER WITH A GLUCOSE IV. SHE WAS TRANSPORTED TO THE HOSPITAL AND OBSERVED FOR A FEW HOURS. THE ALLEGED PRODUCT WAS REQUESTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767698 ACCU-CHEK ® INSIGHT METER BLOOD GLUCOSE MONITORING DEVICE NBW NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Hospitalization| H| R| R CUSTOMER DECLINED TO PROVIDE OTHER MEDICATIONS| LISARTIN| NOVO-RAPID INSULIN| CUSTOMER DECLINED TO PROVIDE OTHER MEDICATIONS