BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHEMSTRIP ® 10 MD

    MDR report key: 6979057 · Received October 26, 2017

    Report

    Report Number
    1823260-2017-02421
    Event Type
    Malfunction
    Date Received
    October 26, 2017
    Date of Event
    October 3, 2017
    Report Date
    November 21, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JIL
    PMA / PMN Number
    K032437
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S PRODUCT WAS NOT RETURNED FOR INVESTIGATION, SO NO FURTHER INVESTIGATION WAS POSSIBLE. RETENTION MATERIAL OF TEST STRIP LOT 152299 WAS MEASURED ON A RETENTION METER USING NATIVE URINE AND A LEUKOCYTE DILUTION SERIES. THE TEST STRIPS WERE VISUALLY CHECKED. THE RESULTS OF THE MEASUREMENTS FULFILLED REQUIREMENTS AND NO FALSE NEGATIVE RESULTS WERE OBSERVED. NO FURTHER CUSTOMER COMPLAINTS HAVE BEEN RECEIVED FOR TEST STRIP LOT 152299. THE CUSTOMER WAS USING EXPIRED TEST STRIPS. IT IS HIGHLY RECOMMENDED TO NOT USE EXPIRED TEST STRIPS.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY RECEIVED ERRONEOUS RESULTS FOR TWO PATIENTS TESTED WITH CHEMSTRIP 10 MD URINE TEST STRIPS ON URISYS 1000 URINE ANALYZER SERIAL NUMBER (B)(6). THE CUSTOMER IS NOT SURE OF THE DATE OF THE EVENT AND STATED THAT THE EVENT MOST LIKELY OCCURRED ONE WEEK PRIOR TO (B)(6) 2017. THE PATIENTS HAD NEGATIVE OR TRACE LEUKOCYTE RESULTS WHEN TESTED USING THE TEST STRIPS AND URISYS 1100 ANALYZER. THE DOCTOR LOOKED AT THE PATIENT URINE SAMPLES UNDER A MICROSCOPE AND THERE WERE SO MANY LEUKOCYTES IN THE URINE, THE SAMPLES APPEARED TO BE "2+". NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENTS. THE METER WAS NOT EXPOSED TO DIRECT SUNLIGHT. THE CUSTOMER IS NOT SURE IF THE URINE SAMPLES WERE SWIRLED PRIOR TO TESTING. QUALITY CONTROLS WERE TESTED AND THESE WERE WITHIN RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760685 CHEMSTRIP ® 10 MD URINE TEST STRIPS JIL ROCHE DIAGNOSTICS NA 15229901

    Patients

    Seq Age Sex Outcome Treatment
    1