BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAUNDICE JM105

    MDR report key: 20247746 · Received September 18, 2024

    Report

    Report Number
    2510954-2024-00042
    Event Type
    Malfunction
    Date Received
    September 18, 2024
    Report Date
    October 4, 2024
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC
    Product Code
    MQM
    UDI-DI
    04049098000246
    PMA / PMN Number
    K133175
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A COMPLAINT WAS RECEIVED REGARDING A JM105 WITH LOWER READINGS THAN THE TOTAL SERUM BILIRUBIN (TSB). NO ADVERSE PATIENT IMPACT WAS REPORTED. THE DEVICE WAS SENT TO TELFORD FOR ANALYSIS AND ACCORDING TO SERVICE NOTE ORDER (B)(4) THE METER PASSED THE PRE-INSPECTION TEST, AND THE TEST CHECKER READINGS WERE WITHIN TOLERANCE. THE ENGINEER RECALIBRATED THE DEVICE FOR CUSTOMER SATISFACTION AND ALL THE FUNCTIONS OF THE JM105 PASSED POST CALIBRATION, AND THE DEVICE WAS SENT BACK TO THE CUSTOMER. THE CUSTOMER PROVIDED PATIENT JAUNDICE METER READINGS AND BLOOD READINGS COMPARISON DATA ALONG WITH ANSWERS TO THE JM105 CLINICAL QUESTIONS. BASED ON THE INFORMATION GIVEN BY THE USER, CRITERIA FOR PROPER USE OF THE JM105 AND FOR PROCESSING THE BLOOD FOR TSB MEASUREMENTS WERE BEING MET. AN ANALYSIS OF THE DATA PROVIDED DID NOT RESULT IN A PRECISE ROOT CAUSE EXPLAINING THE VALUES THAT WERE NOT WITHIN THE 1.5 DEVIATION, WHICH DRAGER HAS DETERMINED THROUGH CLINICAL TRIALS TO BE ACCEPTABLE DEVIATIONS. BECAUSE THERE WAS NO MALFUNCTION FOUND WITH THE DEVICE AND ADDITIONAL TRAINING WITH THE USE OF THE JAUNDICE METER DOES NOT APPEAR TO BE NEEDED AT THIS TIME, AN EXACT ROOT CAUSE CANNOT BE DETERMINED. NO FURTHER ISSUES HAVE BEEN REPORTED WITH THIS DEVICE. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) THE JM105 JAUNDICE METER IS TO BE USED A SCREENING DEVICE IN CONJUNCTION WITH OTHER CLINICAL SIGNS AND LABORATORY MEASUREMENTS PRIOR TO MAKING TREATMENT DECISIONS.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE JAUNDICE METER (JM) 105 GAVE "MOSTLY" LOW READINGS. NO ADVERSE PATIENT IMPACT OR PATIENT DEATH WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE JAUNDICE METER (JM) 105 GAVE "MOSTLY" LOW READINGS. NO ADVERSE PATIENT IMPACT OR PATIENT DEATH WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1302261 JAUNDICE JM105 JAUNDICE METER/BILIRUBINOMETER MQM DRAEGER MEDICAL SYSTEMS, INC 04049098000246

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown N/A.| N/A.