BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAUNDICE JM105

    MDR report key: 20246056 · Received September 18, 2024

    Report

    Report Number
    2510954-2024-00039
    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 CUSTOMER PROVIDED PATIENT JAUNDICE METER READINGS AND BLOOD READINGS COMPARISON DATA ALONG WITH ANSWERS TO THE JM105 CLINICAL QUESTIONS. AN ANALYSIS OF THE DATA SHOWED OUT OF THE 23 ELIGIBLE CHECKS, 8 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 SHOULD FALL WITHIN THE STANDARD DEVIATION RANGE. THE ELIGIBLE READINGS THAT WERE PROVIDED WOULD INDICATE A 32% PASS RATE HOWEVER, SOME OF THE CLINICAL DATA SUCH AS HOURS OF LIFE AND SKIN TYPE OF SOME OF THE PATIENTS WAS MISSING. IN ADDITION, SEVERAL REQUESTS WERE MADE TO DETERMINE IF THE CUSTOMER WAS PROCESSING THE TSB IN THE LAB WITHIN THE 1HOUR TIMEFRAME, BUT THIS INFORMATION WAS NOT MADE AVAILABLE. THE DEVICE WAS SENT TO TELFORD

    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
    1384521 JAUNDICE JM105 JAUNDICE METER/BILIRUBINOMETER MQM DRAEGER MEDICAL SYSTEMS, INC. 04049098000246

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown