BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® INSIGHT METER

    MDR report key: 6086441 · Received November 8, 2016

    Report

    Report Number
    3011393376-2016-07158
    Event Type
    Injury
    Date Received
    November 8, 2016
    Date of Event
    September 22, 2016
    Report Date
    July 24, 2025
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL MDR IS BEING SUBMITTED AS A PART OF A RETROSPECTIVE REVIEW AND REMEDIATION EFFORT BASED ON ERRORS THAT OCCURRED IN THE SUBMISSION OF MDRS FOR INCORRECT MANUFACTURER NAME AND/OR ADDRESS. A NON-CONFORMANCE REPORT (NCR) ¿ 16847 TO IMPLEMENT CORRECTIVE ACTIONS WAS OPENED ON JANUARY 29, 2025. DEVICE PERFORMANCE AND/OR RISK PROFILE ARE NOT IMPACTED.

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED OUTSIDE OF THE UNITED STATES WHILE THIS PRODUCT IS NOT SOLD IN THE UNITED STATES, IT IS LIKE OR SIMILAR TO A PRODUCT MARKETED IN THE UNITED STATES.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS HOSPITALIZED FOR HYPOGLYCEMIA WHILE USING THE BLOOD GLUCOSE MONITOR. IT WAS REPORTED THAT THE PATIENT'S TEACHER MISTAKENLY ENTERED THE AMOUNT OF CARBS WHERE THE AMOUNT OF INSULIN IS SUPPOSED TO BE ENTERED; THEREFORE THE PATIENT RECEIVED 4.5 IU, WHEN HE ONLY NEEDED 0.8IU. THE PATIENT EXPERIENCED LOW BLOOD GLUCOSE SYMPTOMS. AT SCHOOL HE WAS TREATED WITH "7 KE" OF CARBS TO INCREASE HIS BLOOD GLUCOSE LEVEL. AT AN UNKNOWN TIME THE PATIENTS BLOOD GLUCOSE RESULT WAS STILL LOW AT 75 MG/DL. THE MOTHER TRANSPORTED THE PATIENT TO THE HOSPITAL. THE BLOOD GLUCOSE RESULTS OBTAINED AT THE HOSPITAL WERE NOT PROVIDED. THE HOSPITAL TREATED THE PATIENT WITH "15 KE" OF CARBS. THE HOSPITAL RETESTED THE PATIENTS BLOOD GLUCOSE AND HIS RESULTS WERE NORMAL. THE PATIENT WAS HOSPITALIZED FOR ONE DAY. THE SERIAL NUMBER WAS NOT PROVIDED. THE PRODUCT IS NOT EXPECTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736911 ACCU-CHEK ® INSIGHT METER BLOOD GLUCOSE MONITORING DEVICE NBW ROCHE DIABETES CARE, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Male Hospitalization| R