BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE DROP CHROME BGMS

    MDR report key: 7041269 · Received November 17, 2017

    Report

    Report Number
    3004637226-2017-00013
    Event Type
    Injury
    Date Received
    November 17, 2017
    Date of Event
    October 19, 2017
    Report Date
    November 17, 2017
    Manufacturer
    AGAMATRIX, INC.
    Product Code
    NBW
    UDI-DI
    00859509006019
    PMA / PMN Number
    K161834
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REQUESTED BUT HAS NOT BEEN RETURNED TO THE MANUFACTURER. THE METER DHR WAS REFERENCED AND THE METER LEFT THE MANUFACTURER WITHIN SPECIFICATION. THE REPORTED TEST STRIP LOT DHR WAS REFERENCED AND THE LOT CLEARED QC FOR RELEASE. THE OWNER'S GUIDE AND PREVIOUS FIELD RETURNS HAVE BEEN REVIEWED. THERE IS NO EVIDENCE THE EVENT WAS CAUSED BY IMPROPER LABELING. THERE IS NO EVIDENCE FROM PREVIOUS FIELD RETURNS THE EVENT WAS CAUSED BY A METER MALFUNCTION. BASED ON THE INFORMATION PROVIDED, THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED THOUGH INSULIN, OTHER MEDICATION, DIET AND EXERCISE MAY HAVE BEEN A CAUSE. FACTORS SUCH AS HEMATOCRIT, TEMPERATURE, HUMIDITY, ELEVATION, AND TESTING PROCEDURE MAY HAVE CONTRIBUTED TO THE DISCREPANT READINGS. NO CORRECTIVE ACTION WILL BE PERFORMED BECAUSE NO SYSTEM ERROR CAN BE CONFIRMED. THIS EVENT WILL CONTINUE TO BE TRENDED.

    Description of Event or Problem · 1

    PATIENT CALLED IN BECAUSE THE ONE DROP CHROME METER IS SHOWING READINGS THAT ARE HIGHER THAN USUAL FOR HIM, EVEN WHEN HE HAS SYMPTOMS OF LOW BLOOD GLUCOSE. ADDITIONALLY, THE ONE DROP CHROME IS REPORTED TO MEASURE BLOOD-GLUCOSE 20-50 MG/DL HIGHER THAN HIS EMBRACE PRO. HE MEASURES HIS BLOOD-GLUCOSE 4-7 TIMES AND INJECTS ABOUT 40 UNITS OF INSULIN PER DAY. THE NIGHT PREVIOUS TO CALLING, HE FELT LIKE HIS BLOOD-GLUCOSE WAS GETTING LOW SO HE MEASURED WITH HIS ONE DROP CHROME (75 MG/DL) BUT REPORTED NEVER EXPERIENCING SYMPTOMS OF HYPOGLYCEMIA AT 75 MG/DL. HIS SYMPTOMS WORSENED SO HE CHECKED WITH HIS EMBRACE PRO (35 MG/DL). THIS MEASUREMENT WAS REPORTED TO OCCUR 5-10 MINUTES AFTER THE FIRST. THERE IS NO INDICATION THAT MEDICAL PERSONNEL WERE REQUIRED TO STABILIZE HIS BLOOD-SUGAR. NO INFORMATION WAS PROVIDED ON WHETHER INSULIN WAS ADMINISTERED IN RESPONSE TO A ONE DROP CHROME MEASUREMENT PRIOR TO THE EVENT, AND IF SO, NEITHER THE MEASUREMENT VALUE NOR THE DOSAGE WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    821998 ONE DROP CHROME BGMS BLOOD GLUCOSE METER NBW AGAMATRIX, INC. 8000-10465 00859509006019

    Patients

    Seq Age Sex Outcome Treatment
    1 Other