BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAUNDICE JM105

    MDR report key: 19580978 · Received June 21, 2024

    Report

    Report Number
    2510954-2024-00028
    Event Type
    Malfunction
    Date Received
    June 21, 2024
    Report Date
    August 7, 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
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED TO DRAEGER THAT THE JM105 JAUNDICE METER WAS PROVIDING INCONSISTENT READINGS OUTSIDE OF THE 1.5 STANDARD DEVIATION WHEN COMPARED TO TSB VALUES. THE CUSTOMER PROVIDED A DATA SHEET AND THE ANSWERS TO THE CLINICAL QUESTIONS HOWEVER, WHEN THEIR DATA WAS ANALYZED, IT WAS FOUND THAT ONLY 17 CHECKS WERE ELIGIBLE READINGS HAVING HAD THE BLOOD PROCESSED WITHIN THE 1-HOUR TIME FRAME. OUT OF THE 17 ELIGIBLE CHECKS, 13 WERE FOUND TO BE WITHIN THE DRAEGER STANDARD DEVIATION OF PLUS OR MINUS 1.5 AS OUTLINED IN THE INSTRUCTIONS FOR USE (IFU). THE IFU FURTHER STATES THAT BASED ON THE AVERAGE OF CLINICAL DATA AVAILABLE, 66% OF THE VALUES TAKEN WITH THE JM105 FALL WITHIN THE STANDARD DEVIATION RANGE. ACCORDING TO THE DATA PROVIDED BY THE CUSTOMER, THEIR DATA SHOWED THIS UNIT TO HAVE GIVEN VALUES WITHIN RANGE 76% OF THE TIME. THE METER WAS ANALYZED BY DRAEGER AND DURING THE PRE-CALIBRATION INSPECTION OF THE DEVICE THE DRAEGER ENGINEER DISCOVERED THAT THE VALUES WERE WITHIN RANGE HOWEVER, THE SHORT-WAVE VALUE (.6) WAS CLOSER TO THE LOW SIDE WHEN COMPARED TO THE TOLERANCES GIVEN ON THE BASE (THE RANGE FOR THE SHORT-WAVE ACCEPTABLE VALUE WAS -2.3 TO .3). THIS DEVICE WAS LAST CALIBRATED ON 09NOV2023, BUT THE ENGINEER RECOMMENDED ANOTHER CALIBRATION. THE DEVICE WAS CALIBRATED TO SATISFACTORY STANDARDS WITH THE VALUES FALLING WITHIN THE TOLERANCE RANGES. THE ROOT CAUSE OF THE INCONSISTENT READINGS THE CUSTOMER IS REPORTING COULD NOT BE DETERMINED AS THERE WAS NO MENTION OF DEVICE DAMAGE BY THE ENGINEER AND NO REPAIRS TO THE DEVICE WERE REQUIRED. THE DEVICE WAS RETURNED TO THE CUSTOMER. NO FURTHER ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT A JAUNDICE METER READS OUTSIDE OF THE TOLERANCE 1.5, + OR - AT LEAST 66% OF THE TIME WHEN COMPARED TO SERUM BILIRUBIN. THERE WAS NO REPORT OF A PATIENT INJURY OR DEATH.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT A JAUNDICE METER READS OUTSIDE OF THE TOLERANCE 1.5, + OR - AT LEAST 66% OF THE TIME WHEN COMPARED TO SERUM BILIRUBIN. THERE WAS NO REPORT OF A PATIENT INJURY OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1182686 JAUNDICE JM105 JAUNDICE METER/BILIRUBINOMETER MQM DRAEGER MEDICAL SYSTEMS, INC 04049098000246

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown