BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JM-105 JAUNDICE METER

    MDR report key: 16454284 · Received February 28, 2023

    Report

    Report Number
    2510954-2023-00001
    Event Type
    Injury
    Date Received
    February 28, 2023
    Date of Event
    February 20, 2023
    Report Date
    February 28, 2023
    Manufacturer
    DRAEGER MEDICAL INFANT CARE, INC.
    Product Code
    MQM
    PMA / PMN Number
    K133175
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING INFORMATION WAS REQUESTED HOWEVER, WHEN CONTACTED, THE CUSTOMER CONFIRMED THE EVENT OCCURRED BUT STATED THAT NO FURTHER INFORMATION WAS AVAILABLE. THE CUSTOMER USES A 3RD PARTY TO SERVICE THE DEVICE. THEREFORE, NO FURTHER INVESTIGATION IS POSSIBLE AND ROOT CAUSE OF THE REPORTED ISSUE CANNOT BE DETERMINED. **********INFORMATION REQUESTED - PLEASE CONFIRM THE FOLLOWING: A JAUNDICE METER READING WAS TAKEN AT APPROXIMATELY 15:48 AND BASED ON THOSE READINGS, TREATMENT INCLUDING "CLOSTRIDIUM OXYLIDIUM DUAL VIABLE BACTERIA AND DOUBLE-SIDED BLUE LIGHT TREATMENT FOR 16 HOURS" WAS PROVIDED. AT APPROXIMATELY 18:53, BLOOD SERUM TEST RESULTS WERE RECEIVED WHICH WERE HIGHER THAN INDICATED BY THE JAUNDICE METER READINGS. THE HIGHER READINGS INDICATED A BLOOD TRANSFUSION AND ADDITIONAL PHOTOTHERAPY TIME WAS REQUIRED FOR TREATMENT. NO ADVERSE PATIENT IMPACT WAS REPORTED. AS THIS WOULD INDICATE A DELAY IN TREATMENT, THIS WOULD BE CONSIDERED AN INJURY FOR VIGILANCE REPORTING GUIDELINES. NOTE THAT THE INSTRUCTIONS FOR USE (IFU) STATES JAUNDICE METER READINGS RESULTS SHOULD BE EVALUATED BY A PHYSICIAN FOR APPROPRIATE PATIENT MANAGEMENT. SPECIFIC NEONATAL PATIENT BILIRUBIN LEVELS SHOULD BE CONFIRMED BY OTHER METHODS, SUCH AS SERUM BILIRUBIN, PRIOR TO TREATMENT DETERMINATIONS AND PROVIDES THE FOLLOWING WARNING RISK OF PATIENT INJURY THE DEVICE IS NOT INTENDED AS A STAND-ALONE SCREENING DEVICE FOR DIAGNOSIS OF HYPERBILIRUBINEMIA. IT IS USED AS A SCREENING DEVICE WITH OTHER CLINICAL SIGNS AND LABORATORY MEASUREMENTS. IN ORDER TO INVESTIGATE THE REPORTED ISSUE WE WOULD NEED THE FOLLOWING INFORMATION. IS THIS CUSTOMER: PROPERLY TRAINED THRU PERSONNEL OR VIDEO IN-SERVICE? USING SINGLE MEASUREMENT OR AVERAGES? ENSURING CORRECT POSITION OF THE MEASURING PROBE ON THE SKIN. CONSIDERING THE HOURS OF LIFE OF THE BABY? USING DR. MAISELS TCB NOMOGRAM? OR DR. BUTHANI'S TSB NOMOGRAM? OR ANY OTHER NOMOGRAM? CORRELATING THE JAUNDICE METER WITH A SINGULAR TSB LAB EQUIPMENT? IS THIS CUSTOMER'S LAB EQUIPMENT CALIBRATED? DO THEY USE A BLOOD GAS ANALYZER TO MEASURE TSB? COLLECTING TCB VALUES AT THE SAME TIME BLOOD IS DRAWN? IS THE BLOOD WORK (TSB) PROCESSED BY THE LAB WITHIN 60 MINUTES FROM EXTRACTION? DOCUMENTING THE CAREGIVER DOING THE MEASUREMENTS DURING THE CORRELATION DATA COLLECTION EXERCISE. ENSURING USE OF THE DEVICE IN RIGHT PATIENT POPULATION? (=24 WEEKS AND BEFORE/DURING/AFTER PHOTOTHERAPY) PERFORMING THE LIGHT SOURCE CHECKER ON THE BASE OF THE JAUNDICE METER? WHAT VALUES ARE THEY GETTING? ANY DEVICE EVALUATION/REPAIR INFORMATION. THE DEVICE SERIAL NUMBER. THE DEVICE SERVICE/REPAIR HISTORY AND WHEN THE LAST CALIBRATION WAS PERFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL AT 15:48 MINUTES ON (B)(6) 2023 DUE TO "SKIN YELLOW FOR 10 DAYS". THE BILIRUBIN VALUE WAS MEASURED PERCUTANEOUS WITH ICTEROMETER [JM-105]. FOREHEAD 17.5MG/ (299.25UMOL/L,) DL, CHEEK 17.4MG/(297.54UMOL/L,) /DL, FRONT CHEST 16.5 (282.15UMOL/L,) MG/DL. ACCORDING TO THE DOCTOR'S ADVICE, CLOSTRIDIUM OXYLIDIUM DUAL VIABLE BACTERIA AND DOUBLE-SIDED BLUE LIGHT TREATMENT FOR 16 HOURS. THE CRITICAL VALUES REPORTED IN THE LABORATORY AT 18:53 SHOWED THE TOTAL BILIRUBIN WAS 433.8UMOL/L, INDIRECT BILIRUBIN 415.98UMOL/L AND INDIRECT BILIRUBIN 17.98UMOL/L, WHICH HAD REACHED THE STANDARD OF BLOOD EXCHANGE. THE DEVIATION BETWEEN THE TWO MEASUREMENTS WAS LARGE, WHICH AFFECTED THE TREATMENT OF CHILDREN. TREATMENT MEASURES: THE FREE BILIRUBIN IN HUMAN BLOOD ALBUMIN WAS NEUTRALIZED AND THE TIME OF PHOTOTHERAPY WAS PROLONGED TO REDUCE THE BILIRUBIN IN THE BLOOD OF THE CHILD. NO ADVERSE PATIENT IMPACT WAS REPORTED TO HAVE OCCURRED AS A RESULT OF THE DELAY IN TREATMENT. NO DEVICE SERIAL NUMBER WAS PROVIDED. DRAEGER IDENTIFIED THAT 2 INSTALLATION REPORTS OF JM105, SN (B)(4) AND SN (B)(4) IN 2021 FOR THIS SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409607 JM-105 JAUNDICE METER JAUNDICE METER/BILIRUBINOMETER MQM DRAEGER MEDICAL INFANT CARE, INC. MU26222

    Patients

    Seq Age Sex Outcome Treatment
    1 11 DA Male Required Intervention