BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSURE PRISM MULTI BLOOD GLUCOSE SYSTEM

    MDR report key: 8570284 · Received May 1, 2019

    Report

    Report Number
    3005621222-2019-00005
    Event Type
    Malfunction
    Date Received
    May 1, 2019
    Date of Event
    February 21, 2019
    Report Date
    July 1, 2019
    Manufacturer
    I-SENS, INC.
    Product Code
    NBW
    UDI-DI
    00015482530501
    PMA / PMN Number
    K131419
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PER EXEMPTION NUMBER E2016001, ARKRAY FACTORY USA, INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF I-SENS, INC. (MANUFACTURER). METER WAS RETURNED TO MANUFACTURER AND TESTED. IN THE CONTROL SOLUTION TEST WITH THE RETURNED METER, ALL READINGS WERE IN THE ERROR TOLERANCE AND MET THE STANDARD RANGE OF CV%. AS A RESULT OF DISSASSEMBLING THE METER, IT WAS DISCOVERED THAT A LIQUID FOREIGN SUBSTANCE HAD FLOWED INTO THE INSIDE OF THE METER. IT IS ASSUMED THAT THE RETURNED METER FUNCTIONED PROPERLY AGAIN AFTER THE LIQUID FOREIGN SUBSTANCE HAD BEEN REMOVED OR DISPLACED BY REPEATED STRIP INSERTIONS. IMPROPER USE. COMPLAINT CLOSED.

    Additional Manufacturer Narrative · 0

    PER EXEMPTION NUMBER E2016001. CUSTOMER ONLY RETURNED FOUR STRIPS OF SPECIFIED LOT, WHICH WERE TESTED WITH ANOTHER METER COMPLAINT FROM THE SAME CUSTOMER. ALL TESTING WAS DONE USING RETAIN OR REFERENCE STRIPS. LEVEL 1 AND 2 CONTROL SOLUTION TESTING FAILED WHEN USING RETURNED METER CONFIRMING THE COMPLAINT. RETURNED CONTROL SOLUTION ONLY PASSED TESTING WHEN USING RETAIN STRIPS WITH QS METER. BLOOD TESTING WAS ALSO PERFORMED WITH RETURNED METER AND RETAIN STRIPS OF SPECIFIED LOT AND THE 150 MG/DL AND 300 MG/DL BLOOD LEVELS FAILED TESTING WITH BLOOD READING LOW RESULTS. THESE RESULTS INDICATE THIS IS A METER ISSUE. PRODUCT WILL BE SHIPPED TO THE MANUFACTURER FOR FURTHER INVESTIGATION AND ROOT CAUSE ANALYSIS.

    Description of Event or Problem · 0

    CUSTOMER CALLED IN BECAUSE METER WAS READING OUT OF RANGE FOR HIGH AND LOW CONTROL SOLUTION. VERIFIED CUSTOMER WAS USING L1 & L2 CS FOR PRISM. CUSTOMER WENT THROUGH CS TEST WITH NEW BOTTLE OF CONTROL SOLUTION AND PRISM STRIPS. VERIFIED CUSTOMER PLACED DROP ON TOP OF BOTTLE CAP. CONTROL TEST FOR NORMAL WAS 87 AND HIGH WAS 93. RANGE ON BOTTLE SHOWS L1 AT 110-165 AND L2 AT 194-291. VERIFIED METER AND STRIPS ARE KEPT TOGETHER IN ORANGE CASE THAT IS INSIDE DUFFLE BAG LOCATED IN TRUCK THAT IS IN A CONTROLLED TEMPERATURE. NO DAMAGE TO METER. METER, STRIPS, AND CS HAVE BEEN REPLACED BY SALES REP. SENDING OUT RETURN LABEL FOR PRODUCTS AND EXPLAINED HOW TO RETURN PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365104 ASSURE PRISM MULTI BLOOD GLUCOSE SYSTEM BLOOD GLUCOSE TEST SYSTEM NBW I-SENS, INC. 530001 PM17MAY2D 00015482530501

    Patients

    Seq Age Sex Outcome Treatment
    1