BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IBGSTAR BGMS

    MDR report key: 4888861 · Received July 2, 2015

    Report

    Report Number
    3004637226-2015-00028
    Event Type
    Injury
    Date Received
    July 2, 2015
    Report Date
    August 5, 2015
    Manufacturer
    AGAMATRIX, INC.
    Product Code
    NBW
    PMA / PMN Number
    K103544
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN REQUESTED AND HAS BEEN RETURNED TO THE MANUFACTURER. THE TEST STRIP LOT DHR WAS REFERENCED AND THE LOT CLEARED QC FOR RELEASE. CONFIRMATION TESTING ON THE METER FOUND A SOLDER JOINT FAILURE FOR THE MASTER CONTROL UNIT (MCU). THIS SOLDER FAILURE WAS DUE TO STRESS APPLIED TO THE PRINTED CIRCUIT BOARD (PCB). CONFIRMATION TESTING FOUND CONTROL SOLUTION TESTING ABOVE THE ACCEPTABLE RANGE AND THE CALCULATION TIMES LONGER THAN NORMAL. ADJUSTED WHOLE BLOOD WAS ALSO TESTED. THE ONLY DISPLAYED RESULTS WERE ERROR 4. THIS CONFIRMS THE CUSTOMER'S COMPLAINT OF EXPERIENCING ERROR 4 BEFORE THE EVENT. TESTING ADJUSTED WHOLE BLOOD YIELDED ONLY ERROR 4. A RESULT WAS NEVER PRODUCED WHEN BLOOD WAS APPLIED TO THE SYSTEM. THE SOLDER ISSUE HAD PREVIOUSLY BEEN IDENTIFIED AND IS A KNOWN FAILURE MODE. AN INVESTIGATION CONCLUDED THE METER WILL NOT RECEIVE A BLOOD-GLUCOSE READING WHILE IT IS EXPERIENCING THIS FAILURE. INSTEAD, IT WILL DISPLAY THE ERROR 4 MESSAGE WHENEVER BLOOD IS TESTED. THE ADJUSTED WHOLE BLOOD TESTS PERFORMED WITH THIS METER CONFIRMS THE INVESTIGATION'S RESULTS. A CORRECTIVE ACTION WAS IMPLEMENTED 12 JAN 2013. THE METER INVOLVED WITH THIS EVENT WAS MANUFACTURED 10 JUL 2012, BEFORE THE IMPLEMENTATION OF THE CORRECTIVE ACTION. THE CORRECTIVE ACTION HAS BEEN EFFECTIVE IN REDUCING THE INCIDENCE RATE OF THE MCU SOLDER FAILURE. METERS PRODUCED BEFORE THE FIX HAVE A FAILURE RATE OF 0.25 %. METERS PRODUCED AFTER THE FIX HAVE A FAILURE RATE OF 0.093 %. BASED ON THE LIMITED INFORMATION PROVIDED, THE ROOT CAUSE OF THE INCIDENT COULD NOT BE DETERMINED. INSULIN MAY HAVE CONTRIBUTED TO THE HYPOGLYCEMIC SYMPTOMS. FACTORS SUCH AS HEMATOCRIT, TEMPERATURE, HUMIDITY, ELEVATION, OTHER MEDICATION, AND TESTING PROCEDURE MAY HAVE CONTRIBUTED TO THE DISCREPANT VALUES. SINCE THE FAILURE MODE HAS BEEN IDENTIFIED AND CORRECTED, NO FURTHER CORRECTIVE ACTIONS WILL BE IMPLEMENTED AT THIS TIME. THIS COMPLAINT WILL CONTINUE TO BE TRENDED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN REQUESTED BUT HAS NOT BEEN RETURNED TO THE MANUFACTURER. THE METER DHR WAS REFERENCED. THIS SHOWS THE METER LEFT THE FACTORY OPERATIONAL. TEST STRIP LOT DHR WAS REFERENCED AND THE LOT WAS CLEARED FOR RELEASE. THE OWNER'S GUIDE AND PREVIOUS FIELD RETURNS HAVE BEEN REVIEWED. THERE IS NO EVIDENCE FROM PREVIOUS FIELD RETURNS THE EVENT WAS CAUSED BY A METER MALFUNCTION. BASED ON THE LIMITED INFORMATION PROVIDED, THE ROOT CAUSE OF THE ERRORS CANNOT BE DETERMINED. THEY WERE MOST LIKELY CAUSED BY TEMPERATURE OUT OF RANGE (ERROR 4) AND A COMBINATION OF HIGH GLUCOSE AND OTHER MEDICAL CONDITIONS (ERROR 5). BASED ON THE LIMITED INFORMATION PROVIDED, THE ROOT CAUSE OF THE INCIDENT COULD NOT BE DETERMINED. INSULIN MAY HAVE CONTRIBUTED TO THE HYPOGLYCEMIC SYMPTOMS. FACTORS SUCH AS HEMATOCRIT, TEMPERATURE, HUMIDITY, ELEVATION, OTHER MEDICATION, AND TESTING PROCEDURE MAY HAVE CONTRIBUTED TO THE DISCREPANT VALUES. NO CORRECTIVE ACTION WILL BE INITIATED BECAUSE SYSTEM FAILURE COULD NOT BE CONFIRMED. THIS EVENT WILL CONTINUE TO BE TRENDED.

    Description of Event or Problem · 1

    THE PATIENT REPORTED EXPERIENCING HYPOGLYCEMIA DURING THE NIGHT. THE DEVICE HAD SHOWN ERRORS 4 AND 5 FOR THE PAST COUPLE OF DAYS. IN THE EVENING, HER IBGSTAR METER MEASURED HER GLYCEMIA AT 200 MG/DL. SHE INJECTED BASAL INSULIN TO REGULATE HER GLYCEMIA. DURING THE NIGHT SHE FELT HYPOGLYCEMIC SYMPTOMS LIKE SWEAT AND DIZZINESS. SHE MEASURED HER BLOOD GLUCOSE AND THE DEVICE GAVE INCONSISTENT VALUES SUCCESSIVELY : 133, 51, 145, 43 AND 170 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432043 IBGSTAR BGMS BLOOD GLUCOSE METER NBW AGAMATRIX, INC. 8000-05716 LU23WD37J

    Patients

    Seq Age Sex Outcome Treatment
    1 Other