BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EREADER+ DRUG SCREENING INSTRUMENT

    MDR report key: 24562602 · Received March 10, 2026

    Report

    Report Number
    2032598-2026-00001
    Event Type
    Malfunction
    Date Received
    March 10, 2026
    Date of Event
    February 13, 2026
    Report Date
    March 10, 2026
    Manufacturer
    AMEDITECH, INC.
    Product Code
    JJQ
    UDI-DI
    00816565021530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A CUSTOMER ALLEGED THEIR EREADER+ PRODUCED SMOKE. UPON ANALYSIS, NO DEVIATIONS WERE FOUND FROM THE EREADER+ BUT DAMAGE WAS VISIBLE NEAR THE INSTRUMENT POWER SUPPLY. COMPLAINT / ATTACHMENT / LABELING REVIEW: ON (B)(6) 2026, TECHNICAL SERVICE (TS) RECEIVED A COMPLAINT FROM ESCREEN QA VIA CALL TRACKING REPORTING THAT THE EREADER+ (S/N (B)(6)) WAS ¿SMOKING FROM THE CABLES AT THE BACK¿ WHEN THE CLINIC ATTEMPTED TO USE THE DEVICE AT THE START OF THE DAY. THE CLINIC CONFIRMED THAT NO TESTS WERE BEING PERFORMED WHEN THE SMOKE WAS OBSERVED. THE CLINIC DECLINED TIER 1 TROUBLESHOOTING, AND THE CASE WAS TRANSFERRED TO TECHNICAL SUPPORT. THE DEVICE WAS APPROVED FOR RETURN AND AN RMA WAS ISSUED. EVENT DETAILS WERE DOCUMENTED UNDER CLINIC (B)(6), CALL TICKET (B)(4), AND ORDER (B)(4). NO PHYSICAL DAMAGE WAS REPORTED AT INTAKE, ALTHOUGH THE CLINIC NOTED VISIBLE SMOKE NEAR THE POWER PORT AREA. ON (B)(6) 2026, TS CONTACTED THE CLINIC FOR ADDITIONAL SAFETY RELATED INFORMATION. THE CLINIC REPORTED NO VISIBLE SIGNS OF BURNING, SPARKING, FIRE, CHARRING, MELTED PLASTIC, OR ELECTRICAL DISCHARGE; NO BURNING ODORS; NO HEAT FELT ON THE DEVICE OR CABLE; AND NO EXPOSURE TO WATER OR MOISTURE. REVIEW OF ATTACHMENT ¿(B)(4)_RETURN LABEL (B)(4) SN (B)(6)¿ CONFIRMED THAT IT CONTAINED ONLY THE RETURN LABEL WITH NO ADDITIONAL TECHNICAL DETAILS. LABELING AND IFU MATERIALS WERE REVIEWED AND FOUND NOT TO CONTRIBUTE TO THE REPORTED CONDITION. BECAUSE THE ALLEGATION INVOLVED VISIBLE SMOKE, USER ERROR IS NOT CONSIDERED A CONTRIBUTING FACTOR. THE OPERATOR GUIDE (PART NO. (B)(4)), APPROVED UNDER THE TOXICOLOGY MANUFACTURING QMS, WAS REVIEWED; HOWEVER, THE OPERATIONAL ENVIRONMENT AND TESTING CONDITIONS DURING THE EVENT WERE NOT DOCUMENTED AND THEREFORE CANNOT BE ASSESSED. BATCH RECORD REVIEW: INCOMING INSPECTION RECORDS SHOWED THAT S/N (B)(6) HAD A DOCUMENTED CERTIFICATE OF COMPLIANCE AND NO ASSOCIATED QIS. THE INSTRUMENT UNDERWENT POST MANUFACTURING INSPECTION ON (B)(6) 2024 WITH NO DEVIATIONS IDENTIFIED. RETURN ANALYSIS: THE RETURNED EREADER+ WAS DECONTAMINATED AND BROUGHT INTO THE LAB FOR EVALUATION. EXTERNAL VISUAL INSPECTION SHOWED THAT ALL LABELING AND ENCLOSURE FEATURES WERE INTACT, BUT A BURN MARK WAS PRESENT ADJACENT TO THE POWER PORT ON THE BACKSIDE OF THE INSTRUMENT. TO ASSESS WHETHER THE ISSUE ORIGINATED FROM THE POWER SUPPLY OR THE INSTRUMENT, THE RETURNED POWER SUPPLY WAS TESTED ON A KNOWN GOOD EREADER+, WHICH POWERED ON WITHOUT ABNORMALITIES. THE RETURNED USB CABLE ALSO FUNCTIONED PROPERLY. WHEN THE RETURNED EREADER+ WAS TESTED USING THESE SAME PERIPHERALS, THE INSTRUMENT POWERED ON NORMALLY, ESTABLISHED A STABLE COMPUTER CONNECTION, AND COMPLETED FUNCTIONAL OPERATIONS WITHOUT ISSUE. LASER SUBSYSTEM TESTING DEMONSTRATED THAT THE DEVICE SUCCESSFULLY COMPLETED TEN LASER SHOTS WITH AN AVERAGE OUTPUT OF 170 MW, WHICH IS WITHIN SPECIFICATION. LED, CAMERA, AND FIRMWARE PERFORMANCE WERE EVALUATED THROUGH A FULL TEST AND 100 IMAGE LOOPS, DURING WHICH THE LEDS FIRE FOR EACH ILLUMINATION CYCLE AND THE CAMERA CAPTURES AN IMAGE DURING EVERY ITERATION, WHILE THE FIRMWARE MANAGES TEST EXECUTION, COMMUNICATION, AND DATA TRANSFER. INTERNAL INSPECTION REVEALED NO DEBRIS, MOISTURE, OR INTERNAL DAMAGE, AND ALL CIRCUIT BOARDS APPEARED NORMAL. ELECTRICAL TESTING SHOWED THAT THE POWER SUPPLY DELIVERED A STABLE 12 V AND THAT THE INTERNAL CIRCUITRY RECEIVED 12 V AS DESIGNED. THE PROTECTIVE FUSE NEAR THE POWER INPUT SHOWED NO EVIDENCE OF OVERCURRENT OR FAULT ACTIVATION. NO SMOKING, OVERHEATING, SHORT-CIRCUITING, OR BURNING ODORS WERE OBSERVED DURING ANY TESTING. A SMALL AMOUNT OF MELTED PLASTIC WAS IDENTIFIED NEAR THE INTERNAL POWER SUPPLY AREA; HOWEVER, THE CONDITION THAT CAUSED THE ISSUE COULD NOT BE REPRODUCED UNDER CONTROLLED TESTING AND NO ABNORMAL HEAT GENERATION OR SMOKE OCCURRED. THE POWER SUPPLY ELECTRICAL PROTECTIONS ARE VALIDATED BY INTERNATIONAL COMPLIANCE LABORATORIES (ICL) UNDER ¿REPORT 2465B REV3 ABBOTT EREADER+ (IEC),¿ CONFIRMING IMMUNITY TO ESD, RADIATED FIELDS, ELECTRICAL SURGES, MAGNETIC FIELDS, AND VOLTAGE VARIATIONS. IMAGES AND LOG FILES COLLECTED DURING RETURN TESTING ARE STORED IN ¿(B)(4) RETURN ANALYSIS ATTACHMENTS.¿ RISK REVIEW: RISK ASSOCIATED WITH POWER SUPPLY OUTPUT IS CAPTURED IN LINE 410 (¿POWER SUPPLY OUTPUT OVERVOLTAGE¿) OF THE LA JOLLA RISK MANAGEMENT REPORT ((B)(4)). THE MITIGATED PROBABILITY OF HARM IS CLASSIFIED AS IMPROBABLE ((B)(4)) PER THE RISK MANAGEMENT PROGRAM (B)(4). COMPLAINT TRENDING CONFIRMS THAT THIS FAILURE MODE OCCURS WITHIN EXPECTED AND ACCEPTABLE LIMITS. PER CLINICAL EFFECTS REPORT CER019 REV. AB, THE ASSOCIATED HARM IS LIMITED TO DELAYED RESULTS, WHICH DO NOT POSE INJURY OR CLINICAL IMPACT. ANY REQUIRED RETESTING OR RECOLLECTION REPRESENTS INCONVENIENCE RATHER THAN ADVERSE HEALTH CONSEQUENCES. TREND ANALYSIS: A TWO-YEAR REVIEW OF COMPLAINTS (AS OF 19FEB2026) IDENTIFIED THREE RELATED CASES USING KEYWORDS ¿SMOKE,¿ ¿SMOKING,¿ ¿BURNING,¿ OR ¿CHARRING.¿ DURING THIS PERIOD, THE EREADER+ PLATFORM COMPLETED APPROXIMATELY (B)(4) TESTS. THIS CORRESPONDS TO AN OCCURRENCE RATE OF (B)(4), CONSISTENT WITH THE ¿IMPROBABLE¿ CLASSIFICATION (B)(4) DEFINED IN THE RISK MANAGEMENT PROGRAM. THIS RATE ALIGNS WITH EXPECTATIONS DESCRIBED IN RISK TABLE LINE 410. A HELIX DATABASE SEARCH FOUND NO PRIOR COMPLAINTS FOR THIS SERIAL NUMBER. HISTORICALLY, THE INSTRUMENT HAS NOT EXHIBITED ISSUES, AND THIS IS THE FIRST ALLEGATION ASSOCIATED WITH THE ANALYZER SINCE ITS RELEASE. ESCALATION DETERMINATION: THIS EVENT QUALIFIES FOR RMA DUE TO THE CONFIRMED MALFUNCTION. A QI/CAPA IS NOT REQUIRED BECAUSE THIS FAILURE TYPE IS ALREADY RECOGNIZED WITHIN EXISTING CONTROLS, NO NEW CONTRIBUTING FACTORS OR SYSTEMIC CONCERNS WERE IDENTIFIED, AND NO MANUFACTURING DEFECT WAS CONFIRMED. CONCLUSION: THE COMPLAINT WAS CONFIRMED AS AN ALLEGATION; HOWEVER, THE REPORTED SMOKING COULD NOT BE REPRODUCED DURING LABORATORY EVALUATION. WHILE A BURN MARK AND MINOR MELTED PLASTIC WERE OBSERVED IN THE POWER-SUPPLY AREA, THE UNDERLYING ROOT CAUSE OF THE REPORTED SMOKING REMAINS UNDETERMINED. DESPITE THESE FINDINGS, THE INSTRUMENT CONTINUED TO OPERATE WITHIN SPECIFICATION AND DID NOT EXHIBIT ANY ABNORMAL BEHAVIOR DURING TESTING, INCLUDING SMOKING, OVERHEATING, OR PERFORMANCE DEVIATIONS. NO MANUFACTURING ISSUES OR SYSTEMIC CONCERNS WERE IDENTIFIED. THE DEVICE WAS REPLACED THROUGH THE RMA PROCESS, AND NO ADDITIONAL INTERNAL ACTIONS WERE REQUIRED BEYOND ROUTINE COMPLAINT TRENDING AND MONITORING.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED SEEING VISIBLE SMOKE COMING FROM THE POWER JACK IN THE BACK OF AN EREADER+ INSTRUMENT. NO OTHER EVIDENCE OF FIRE (E.G., BURNING, SPARKING, CHARRING, SPARKING, MELTED PLASTIC, ELECTRICAL DISCHARGE) WAS OBSERVED. NO INJURY OR OTHER ADVERSE HEALTH OUTCOME WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617042 EREADER+ DRUG SCREENING INSTRUMENT EREADER+ JJQ AMEDITECH, INC. 55161 00816565021530

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown