BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION

    MDR report key: 11732353 · Received April 27, 2021

    Report

    Report Number
    2517506-2021-00108
    Event Type
    Malfunction
    Date Received
    April 27, 2021
    Date of Event
    March 19, 2021
    Report Date
    June 7, 2021
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    CJW
    UDI-DI
    00842768005343
    PMA / PMN Number
    K861700
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MDRS 2517506-2021-00108 WAS FILED 27-APR-2021. THE FOLOWING MDRS WERE FILED FOR THE SAME EVENT: 2517506-2021-00105, 2517506-2021-00106, 2517506-2021-00107 AND 2517506-2021-00109. SIEMENS HEADQUARTERS SUPPORT CENTER (HSC) CONCLUDED THE INVESTIGATION OF THE DISCORDANT, FALSELY DEPRESSED ALBUMIN (ALB) RESULT OBTAINED ON A PATIENT SAMPLE PROCESSED USING A DIMENSION® EXL¿ 200 SYSTEM. THE PHYSICIAN REQUESTED THE PATIENT SAMPLES BE RETESTED USING TWO DIFFERENT NON-SIEMENS METHODOLOGY SYSTEMS. THE PATIENT SAMPLES RETESTED USING NON-SIEMENS SYSTEMS PRODUCED HIGHER ALB RESULTS. THE HSC INVESTIGATION SHOWED THAT THE ALTERNATE ALBUMIN ASSAYS USED TO COMPARE PATIENT RESULTS TO THE DIMENSION EXL ALB ASSAY WERE ASSAYS THAT UTILIZED A BROMCRESOL GREEN (BCG) REAGENT. THE DIMENSION EXL ALB ASSAY USES A BROMCRESOL PURPLE (BCP) REAGENT. THERE ARE INHERENT DIFFERENCES IN ALB RECOVERY WITH THESE METHODOLOGIES AND RESULTS MAY NOT FULLY CORRELATE ESPECIALLY AT THE LOW END OF THE ALB ANALYTICAL MEASURING RANGE (AMR) DUE TO DIFFERENCES IN SPECIFICITY OF THE ALB ASSAYS. THE SIEMENS BCP ALB ASSAY RECOVERY IS MORE SPECIFIC AND THEREFORE DETECTS FEWER NON-ALBUMIN PROTEINS. FURTHERMORE, THERE ARE OTHER FACTORS WHICH MAY HAVE LED TO LOWER RESULTS ON THE BCP ASSAY VS THE BCG ASSAY. THE CUSTOMER STATED THAT THE SAMPLES IN QUESTION WERE FROM KNOWN DIALYSIS PATIENTS, AND THE BCP ASSAY CAN RECOVER LOWER ON PATIENTS WITH RENAL INSUFFICIENCY SUCH AS THOSE PATIENTS UNDERGOING HEMODIALYSIS. THERE IS ALSO KNOWN INTERFERENCES ON THE DIMENSION EXL BCP ASSAY AS DESCRIBED IN THE INSTRUCTIONS FOR USE (IFU) WITH CMPF (3-CARBOXY-4-METHYL-5-PROPYL-2-FURANPROPANOIC ACID) PRESENT IN THE SERUM OF PATIENTS WITH RENAL FAILURE. BASED ON THE INVESTIGATION, THE SIEMENS ALB ASSAY IS PERFORMING WITHIN SPECIFICATIONS AND NO NON-CONFORMANCES HAVE BEEN IDENTIFIED. THE CUSTOMER IS COMPARING TWO DIFFERENT ALBUMIN ASSAYS WITH KNOWN DIFFERENCES PARTICULARLY AT THE LOW END OF THE AMR. ADDITIONALLY, THE COMPARISON WAS USING SAMPLES FROM PATIENTS UNDERGOING DIALYSIS AND REPORTEDLY EXPERIENCING RENAL INSUFFICIENCY. RESULTS OF THE DIMENSION EXL ALB ASSAY SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH THE PATIENT'S MEDICAL HISTORY, CLINICAL PRESENTATION AND OTHER FINDINGS AS INSTRUCTED IN THE DIMENSION ALB INSTRUCTIONS FOR USE (IFU). THE DEVICE IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION IS REQUIRED. SECTION H6 HAS BEEN UPDATED TO REFLECT THE HSC INVESTIGATION. MDR SUPPLEMENTS 2517506-2021-00105 SUPPLEMENT 1, 2517506-2021-00106 SUPPLEMENT 1, 2517506-2021-00107 SUPPLEMENT 1 AND 2517506-2021-00109 SUPPLEMENT 1 WERE FILED FOR THE SAME EVENT.

    Additional Manufacturer Narrative · 1

    MDRS 2517506-2021-00105, 2517506-2021-00106, 2517506-2021-00107 AND 2517506-2021-00109 WERE FILED FOR THE SAME EVENT. THE CUSTOMER CONTACTED SIEMENS REGARDING DISCORDANT, FALSELY DEPRESSED ALBUMIN (ALB) RESULTS OBTAINED ON PATIENT SAMPLES WITH A DIMENSION® EXL¿ 200 SYSTEM. SIEMENS IS INVESTIGATING THE EVENT.

    Description of Event or Problem · 1

    DISCORDANT FALSELY DEPRESSED SERUM/PLASMA ALBUMIN RESULTS WERE OBTAINED ON PATIENT SAMPLES ON A DIMENSION® EXL¿ 200 SYSTEM. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S) WHO QUESTIONED THE RESULTS. THE CUSTOMER REPROCESSED THE SAME SAMPLES ON TWO ALTERNATE NON-SIEMENS INSTRUMENT SYSTEMS AND HIGHER RESULTS, CONSIDERED CORRECT, WERE OBTAINED. CORRECTED REPORTS WERE ISSUED. THE CUSTOMER STATED THAT THERE WAS SOME DELAY IN OBTAINING RESULTS FOR THE DIALYSIS PATIENTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ALB RESULTS OR THE DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629002 DIMENSION DIMENSION® ALBUMIN FLEX® REAGENT CARTRIDGE (ALB) CJW SIEMENS HEALTHCARE DIAGNOSTICS INC 10444975 NOT PROVIDED 00842768005343

    Patients

    Seq Age Sex Outcome Treatment
    1