BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MASSCHECK® DRIED BLOOD SPOT CONTROL BI-LEVEL (I+II)

    MDR report key: 23209670 · Received October 3, 2025

    Report

    Report Number
    3003951180-2025-00001
    Event Type
    Malfunction
    Date Received
    October 3, 2025
    Manufacturer
    CHROMSYSTEMS INSTRUMENTS & CHEMICALS GMBH
    Product Code
    JJY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FOREIGN CUSTOMER (LOCATED IN GERMANY) REPORTED THE ISSUE INITIALLY. EUROPEAN GDPR RESTRICTS INCLUDING PERSONAL DETAILS. FOR REFERENCE AND FOR FDA FOLLOW-UP WE PROVIDE OUR CHROMSYSTEMS COMPANY RA CONTACT: DR. (B)(6), [email protected], CHROMSYSTEMS INSTRUMENTS & CHEMICALS GMBH, AM HAAG 12, 82166 GRÄFELFING.

    Description of Event or Problem · 0

    IN THE FOLLOWING WE DESCRIBE THE ISSUE REGARDING THE MASSCHECK® DRIED BLOOD SPOT CONTROL BI-LEVEL (I+II)(WITH UDI: (B)(4)(ORDER NO. (B)(4), WHICH ITSELF CONSISTS OF MASSCHECK® DRIED BLOOD SPOT CONTROL LEVEL I (ORDER NO. (B)(4) AND MASSCHECK® DRIED BLOOD SPOT CONTROL LEVEL II (ORDER NO. (B)(4). WE FOUND THAT THE TARGET CONCENTRATION OF PHENYLALANINE INDICATED IN THE LEAFLET, DETERMINED USING THE NON-DERIVATISED METHODS 57000, 57000/F, 57111 AND 57111/F IS TOO HIGH FOR DRIED BLOOD SPOT CONTROL LEVEL I (ORDER NO. (B)(4) AND TOO LOW FOR DRIED BLOOD SPOT CONTROL LEVEL II (ORDER NO. (B)(4). THE CONTROLS ARE PRIMARILY USED TO VERIFY THE ACCURACY AND PRECISION OF THE ANALYTICAL PROCEDURE. IF THE MEASURED VALUES ARE OUTSIDE THE RANGES SPECIFIED ON THE CONTROL PACKAGE INSERT, THE MEASUREMENT SYSTEM, THE SAMPLE PREPARATION PROCEDURE AND THE CALCULATION OF THE ANALYSIS VALUES MUST BE CHECKED. THIS MAY RESULT IN A DELAY OR FAILURE TO TRANSMIT SCREENING RESULTS. FURTHERMORE, THE CONTROLS CAN BE USED TO INTRODUCE OR ADJUST A FACTORISATION (RELATIVE RESPONSE FACTOR, RRF). THIS IS USUALLY USED TO HARMONISE MEASURED VALUES ON DEVICES OVER TIME AND ON DIFFERENT DEVICES AND TO ENABLE THE USE OF A UNIFORM CUT-OFF VALUE. FACTORING IN INCORRECT VALUES ADJUSTS NOT ONLY THE CONTROLS BUT ALSO ALL PATIENT SAMPLES BY THE SAME FACTOR. SINCE THE CUT-OFF VALUE IS NOT ADJUSTED ACCORDINGLY, THERE IS A RISK THAT METABOLIC DISORDERS WILL NOT BE DETECTED IN NEWBORN SCREENING DUE TO INCORRECT FACTORING. IN THE SCENARIOS DESCRIBED, PATIENTS WITH A DISEASE FOR WHICH PHENYLALANINE IS USED AS A MARKER IN NEWBORN SCREENING CAN LEAD TO A CRITICAL CONDITION WITH SERIOUS HEALTH CONSEQUENCES IF THE METABOLIC DISEASE IS NOT DETECTED OR NOT DETECTED IN TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2427404 MASSCHECK® DRIED BLOOD SPOT CONTROL BI-LEVEL (I+II) DRIED BLOOD SPOT CONTROL BI-LEVEL (I+II) JJY CHROMSYSTEMS INSTRUMENTS & CHEMICALS GMBH 0191 4924, 1425

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown