BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAUNDICE JM105

    MDR report key: 19757374 · Received July 16, 2024

    Report

    Report Number
    2510954-2024-00033
    Event Type
    Malfunction
    Date Received
    July 16, 2024
    Report Date
    July 31, 2024
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC.
    Product Code
    MQM
    PMA / PMN Number
    K133175
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION WAS STARTED; RESULTS WILL BE PROVIDED IN A FOLLOW UP-REPORT.

    Additional Manufacturer Narrative · 0

    A COMPLAINT WAS RECEIVED REGARDING THE DRAEGER JM105 JAUNDICE METER WAS PROVIDING INCONSISTENT/LOW READINGS WHEN COMPARED TO TSB VALUES. THE CUSTOMER PROVIDED A DATA SHEET AND THE ANSWERS TO THE CLINICAL QUESTIONS HOWEVER, ADDITIONAL CLINICAL QUESTIONS ASKED BY THE PRODUCT MANAGER DID NOT GENERATE A RESPONSE. IT WAS CONFIRMED BY THE WARRANTY MANAGER THAT THIS DEVICE WAS IN USE WITH THE CUSTOMER FOR 3 TO 4 MONTHS AND A BRIDGE UNIT WAS PROVIDED SO THAT THE METER IN QUESTION COULD BE RETURNED TO THE DRAEGER MEDICAL REPAIR CENTER FOR ANALYSIS. DURING THE PRE-CALIBRATION INSPECTION OF THE DEVICE THE ENGINEER DISCOVERED THAT THE SHORT-WAVE VALUE (.58) WAS ON THE VERY LOW SIDE AND ON THE EDGE OF NOT PASSING WHEN COMPARED TO THE TOLERANCES GIVEN ON THE BASE (THE RANGE FOR ACCEPTABLE VALUE WAS -2.25 TO .5) THIS DEVICE WAS LAST CALIBRATED ON 08DEC2023 HOWEVER, THE ENGINEER RECOMMENDED ANOTHER CALIBRATION. ACCORDING TO THE ATTACHED CALIBRATION CERTIFICATE THE DEVICE WAS CALIBRATED TO SATISFACTORY STANDARDS WITH THE VALUES FALLING WITHIN THE TOLERANCE RANGES. THE ROOT CAUSE OF THE LOW READINGS COULD NOT BE DETERMINED AS THERE WAS NO INDICATION OF DROP DAMAGE ON THE DEVICE AND ACCORDING TO THE WARRANTY MANAGER, NO DEFINITIVE INFORMATION TO SUPPORT WHY THE DEVICE WOULD NEED RECALIBRATION SO SOON AFTER USE BEGAN. THE DEVICE WAS SHIPPED BACK TO THE CUSTOMER WITH THE RECALIBRATED DEVICE BEING READY FOR CLINICAL USE. THE PRODUCT RISK MANAGEMENT REPORT (PRMR) WAS REVIEWED, AND NO NEW RISKS WERE IDENTIFIED. PRODUCT QUALITY WAS NOTIFIED OF THIS ISSUE AND DETERMINED NO FURTHER ACTION WAS REQUIRED AS THE FIELD FAILURE RATE IS ACCEPTABLE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT A JAUNDICE METER READINGS ARE CONSISTENTLY LOWER THAN OUR TSB RESULTS. THERE WAS NO REPORT OF A PATIENT INJURY OR DEATH.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT A JAUNDICE METER READINGS ARE CONSISTENTLY LOWER THAN OUR TSB RESULTS. THERE WAS NO REPORT OF A PATIENT INJURY OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719399 JAUNDICE JM105 JAUNDICE METER/BILIRUBINOMETER MQM DRAEGER MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown