BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 7048794 · Received November 21, 2017

    Report

    Report Number
    2531491-2017-00003
    Event Type
    Malfunction
    Date Received
    November 21, 2017
    Date of Event
    October 26, 2017
    Report Date
    January 10, 2018
    Manufacturer
    ACON LABORATORIES INC
    Product Code
    NBW
    PMA / PMN Number
    K112653
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE INVESTIGATION RETURNED PRODUCT WAS EVALUATED USING CLINICAL SPECIMEN,NO FAILURE DETECTED ALL THE RESULTS WERE FOUND TO BE WITH IN THE PRODUCT SPECIFICATION. WE WILL MONITOR SIMILAR ISSUES IN THE FUTURE.

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS WERE MADE TO GET THE REPORTED PRODUCT BACK BUT THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. DURING THE INVESTIGATION MANUFACTURING AND QC RECORDS WERE REVIEWED AND NO ANOMALIES WERE IDENTIFIED. RETENTION SAMPLES OF THE REPORTED TEST STRIP LOT WERE TESTED USING CONTROL AND CLINICAL SPECIMEN AND ALL THE RESULTS WERE FOUND TO BE WITH IN THE ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    WE RECIEVED A CALL FROM A CUSTOMER, THAT IS HAVING ACCURACY CONCERNS WITH THE ONCALL VIVID BLOOD GLUCOSE METER. THE CUSTOMER GOT THE METER FROM A PHARMACY ON (B)(6) 2017, SO THIS IS NOT AN OUT OF BOX ISSUE. THE CUSTOMER DOES NOT HAVE A BACKUP METER TO USE AND IS INSULIN DEPENDENT. THE CUSTOMER IS VERY CONCERNED ABOUT HIGH READINGS FROM THIS METER. THE CUSTOMER PROVIDED AN EXAMPLE THAT AT 10:00 AM THIS MORNING AFTER TESTING SHE GOT A READING OF 479 FASTING AND SHE WAS NOT FEELING SYMPTOMS OF HIGH BLOOD SUGAR. CUSTOMER ALSO REPORTED THAT OTHER TIMES SHE HAS GOTTEN HIGH READINGS FROM THE METER AND HAS TAKEN INSULIN AND FELT VERY ILL. CUSTOMER CONSIDERED GOING TO THE HOSPITAL THESE TIMES BUT DID NOT. ACON TECHNICAL SPECIALIST TRIED TO GET CUSTOMER TO READ OTHER EXAMPLES FROM THE DEVICES MEMORY BUT CUSTOMER WAS HAVING EXTREME DIFFICULTY WITH THIS. CUSTOMER REPORTED THAT THE STRIPS WERE OPENED 2 WEEKS AGO AND ARE STORED PROPERLY W/ METER. CUSTOMER REPORTED THAT SHE ENCOUNTERED A LOW BG (40 MG/DL) AFTER TAKING INSULIN FOR A READING OF 284 MG/DL. CUSTOMER BELIEVES THE METER WAS FALSELY HIGH AND HER LOW WAS A RESULT OF DOSING BASED ON THAT READING. CUSTOMER RECEIVED HELP FROM THE NEIGHBOR WHO GAVE PEANUT BUTTER TO BRING THE SUGAR LEVEL BACK UP. ON (B)(6) 2017 USER WAS ABLE TO SEND THE REPORTED PRODUCT BACK FOR THE EVALUATION

    Description of Event or Problem · 1

    WE RECEIVED A CALL FROM A CUSTOMER, THAT IS HAVING ACCURACY CONCERNS WITH THE ONCALL VIVID BLOOD GLUCOSE METER. THE CUSTOMER GOT THE METER FROM A PHARMACY ON 6/16/2017, SO THIS IS NOT AN OUT OF BOX ISSUE. THE CUSTOMER DOES NOT HAVE A BACKUP METER TO USE AND IS INSULIN DEPENDENT. THE CUSTOMER IS VERY CONCERNED ABOUT HIGH READINGS FROM THIS METER. THE CUSTOMER PROVIDED AN EXAMPLE THAT AT 10:00 AM THIS MORNING AFTER TESTING SHE GOT A READING OF 479 FASTING AND SHE WAS NOT FEELING SYMPTOMS OF HIGH BLOOD SUGAR. CUSTOMER ALSO REPORTED THAT OTHER TIMES SHE HAS GOTTEN HIGH READINGS FROM THE METER AND HAS TAKEN INSULIN AND FELT VERY ILL. CUSTOMER CONSIDERED GOING TO THE HOSPITAL THESE TIMES BUT DID NOT. ACON TECHNICAL SPECIALIST TRIED TO GET CUSTOMER TO READ OTHER EXAMPLES FROM THE DEVICES MEMORY BUT CUSTOMER WAS HAVING EXTREME DIFFICULTY WITH THIS. CUSTOMER REPORTED THAT THE STRIPS WERE OPENED 2 WEEKS AGO AND ARE STORED PROPERLY W/ METER. CUSTOMER REPORTED THAT SHE ENCOUNTERED A LOW BG (40 MG/DL) AFTER TAKING INSULIN FOR A READING OF 284 MG/DL. CUSTOMER BELIEVES THE METER WAS FALSELY HIGH AND HER LOW WAS A RESULT OF DOSING BASED ON THAT READING. CUSTOMER RECEIVED HELP FROM THE NEIGHBOR WHO GAVE PEANUT BUTTER TO BRING THE SUGAR LEVEL BACK UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830453 ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEM BLOOD GLUCOSE METER NBW ACON LABORATORIES INC OGM-101 890257

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention