BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JM-105 JAUNDICE METER

    MDR report key: 17546187 · Received August 14, 2023

    Report

    Report Number
    2510954-2023-00014
    Event Type
    Malfunction
    Date Received
    August 14, 2023
    Date of Event
    July 13, 2023
    Report Date
    May 20, 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 THE DRAEGER JM105 JAUNDICE METER WAS PROVIDING INCONSISTENT/LOW READINGS. ADDITIONAL INFORMATION WAS PROVIDED; HOWEVER, THE CUSTOMER PROVIDED ONLY TWO MEASUREMENT WHICH IS NOT ENOUGH TO PERFORM DATA ANALYSIS. THE RESPONSE TO THE CLINICAL QUESTIONS CONFIRMED THE METER WAS BEING USED CORRECTLY. THEREFORE, THE REPORTED LOW READING COULD NOT BE VERIFIED. THE METER WAS RETURNED TO THE DREAGER MEDICAL REPAIR CENTER AND NO MALFUNCTION WAS IDENTIFIED. AS A PRECAUTIONARY MEASURE THE SENSOR SET WAS REPLACED, AND THE METER WAS CALIBRATED AND RETURNED TO THE CUSTOMER. ROOT CAUSE OF THE LOW READINGS COULD NOT BE DETERMINED. FOR CUSTOMER SATISFACTION, THE METER WAS REPLACED TO RESOLVE THE ISSUE. NO FURTHER ISSUES HAVE BEEN REPORTED.

    Additional Manufacturer Narrative · 0

    A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THIS INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DRAEGER JM105 JAUNDICE METER WAS PROVIDING INCONSISTENT/LOW READINGS. NO ADVERSE PATIENT IMPACT WAS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DRAEGER JM105 JAUNDICE METER WAS PROVIDING INCONSISTENT/LOW READINGS. NO ADVERSE PATIENT IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56418 JM-105 JAUNDICE METER JAUNDICE METER/BILIRUBINOMETER MQM DRAEGER MEDICAL SYSTEMS, INC 04049098000246

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown