BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAUNDICE JM105

    MDR report key: 20246069 · Received September 18, 2024

    Report

    Report Number
    2510954-2024-00040
    Event Type
    Malfunction
    Date Received
    September 18, 2024
    Report Date
    October 24, 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
    501

    Narratives

    Additional Manufacturer Narrative · 0

    A COMPLAINT WAS RECEIVED REGARDING A DRAEGER JM105 JAUNDICE METER THAT WAS PROVIDING INCONSISTENT READINGS WHEN COMPARED TO TSB VALUES. NO ADVERSE PATIENT IMPACT WAS REPORTED. THE CUSTOMER PROVIDED A DATA SHEET AND THE ANSWERS TO THE CLINICAL QUESTIONS AND UPON REVIEW OF THE LIMITED DATA THEY PROVIDED, THE FIVE ELIGIBLE READINGS WERE LOW WHEN COMPARED TO TSB RESULTS. AN INITIAL REQUEST WAS MADE FOR FURTHER DATA FROM THE CUSTOMER, BUT ADDITIONAL READINGS WERE NOT AVAILABLE. IN THE ORIGINAL EMAIL CORRESPONDENCE ON (B)(6) 2024 THE CUSTOMER STATED THAT THEY DISCOVERED THAT THE LIGHT CHECKER TEST IS NOT PERFORMED BEFORE EVERY MEASUREMENT, BUT WHEN THEY DID CHECK IT, THE S VALUE WAS READING OUT OF RANGE. SEVERAL ATTEMPTS WERE MADE TO DETERMINE HOW OFTEN THE USER WAS PERFORMING THE LIGHT CHECKER TEST, EXACTLY WHEN THEY REALIZED THE S VALUE WAS OUT OF RANGE AND IF THE USER RECEIVED THE "MEASURE READING CHECKER" MESSAGE WHEN THE DEVICE WAS FIRST POWERED ON, BUT THIS INFORMATION WAS NOT MADE AVAILABLE. THE DEVICE WAS RETURNED TO TELFORD FOR ANALYSIS AND ACCORDING TO THE ENGINEER'S (B)(6) 2024 EMAIL, THE S VALUE WAS CONFIRMED TO BE OUT OF RANGE. A RECALIBRATION WAS RECOMMENDED AND THE AFTER-CALIBRATION CHECK CONFIRMED THAT ALL THREE VALUES (LONG, SHORT AND DELTA) WERE WITHIN RANGE ON THE HOUSE CHECKER BASE. ACCORDING TO THE CALIBRATION CERTIFICATE THE SOFTWARE TEST OF THE DEVICE USING THE CALIBRATED CHECKER SETS ALSO SHOWS THAT THE VALUES WERE WITHIN TOLERANCE AFTER THE RECALIBRATION. THE SERVICE NOTE CONFIRMS THAT ALL FUNCTIONS PASSED, AND THE DEVICE WAS SENT BACK TO THE CUSTOMER. THE LAST CALIBRATION OF THE DEVICE WAS (B)(6) 2023 AND THE ROOT CAUSE OF THE METER SHOWING OUT OF RANGE VALUES DURING THE LIGHT-CHECKER TEST AND NEEDING RECALIBRATION BEFORE THE 12-MONTH TIMEFRAME, IS UNKNOWN AT THIS TIME. THE IFU EXPLAINS THAT THE "MEASURE READING CHECKER" WILL APPEAR EACH TIME THE DEVICE IS SWITCHED ON AND CANNOT BE CLEARED UNTIL THIS LIGHT CHECKER TEST IS PERFORMED. THE IFU FURTHER NOTES, THAT JM105 VALUES SHOULD BE PERIODICALLY COMPARED TO SERUM BILIRUBIN RESULTS FOR QUALITY CONTROL PURPOSES AND THAT IF VALUES ARE OUT OF RANGE WITH THE CHARGING BASE, DRAGER SERVICE SHOULD BE CONTACTED. THE JM105 JAUNDICE METER IS A SCREENING DEVICE TO BE USED WITH OTHER CLINICAL SIGNS AND LABORATORY MEASUREMENTS BEFORE MAKING TREATMENT DETERMINATIONS AND IS NOT INTENDED TO BE USED A STAND-ALONE DEVICE FOR DIAGNOSIS OF HYPERBILIRUBINEMIA IS ALSO STATED IN SEVERAL SECTIONS OF THE JM105 INSTRUCTIONS FOR USE (IFU).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A JAUNDICE METER 105 THAT HAD BOTH LOW AND HIGH READINGS. THE METER HAD BEEN IN USE A FEW MONTHS. THE CUSTOMER STATED THAT THE TCB READINGS HAVE BEEN LOWER THAN THE SERUM RESULTS BY 3-4 POINTS WITH A COUPLE RESULTS GREATER THAN THAT, AND THAT THE STAFF WOULD HAVE CHANGED TREATMENT IF THE USERS HAD NOT COLLECTED SERUM. THE STAFF REPORTEDLY CALIBRATE THE UNIT BEFORE EVERY USE. NO ADVERSE PATIENT IMPACT OR DEATH WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A JAUNDICE METER 105 THAT HAD BOTH LOW AND HIGH READINGS. THE METER HAD BEEN IN USE A FEW MONTHS. THE CUSTOMER STATED THAT THE TCB READINGS HAVE BEEN LOWER THAN THE SERUM RESULTS BY 3-4 POINTS WITH A COUPLE RESULTS GREATER THAN THAT, AND THAT THE STAFF WOULD HAVE CHANGED TREATMENT IF THE USERS HAD NOT COLLECTED SERUM. THE STAFF REPORTEDLY CALIBRATE THE UNIT BEFORE EVERY USE. NO ADVERSE PATIENT IMPACT OR DEATH WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1343613 JAUNDICE JM105 JAUNDICE METER/BILIRUBINOMETER MQM DRAEGER MEDICAL SYSTEMS, INC 04049098000246

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown