BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA IM VITAMIN B12 (VB12)

    MDR report key: 15352368 · Received September 2, 2022

    Report

    Report Number
    1219913-2022-00274
    Event Type
    Malfunction
    Date Received
    September 2, 2022
    Date of Event
    July 29, 2022
    Report Date
    December 19, 2022
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    CDD
    UDI-DI
    00630414600284
    PMA / PMN Number
    K993571
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC) TO REPORT DISCORDANT (ELEVATED) ATELLICA IM VITAMIN B12 (VB12) PATIENT RESULTS COMPARED TO LOWER RETEST RESULTS OBTAINED ON A DIFFERENT DAY WITH A DIFFERENT INSTRUMENT AND REAGENT LOT. THE LIMITATIONS SECTION OF THE INSTRUCTIONS FOR USE STATES: "FOR DIAGNOSTIC PURPOSES, THE RESULTS OBTAINED FROM THIS ASSAY SHOULD ALWAYS BE USED IN COMBINATION WITH THE CLINICAL EXAMINATION, PATIENT MEDICAL HISTORY, AND OTHER FINDINGS." SIEMENS IS INVESTIGATING.

    Additional Manufacturer Narrative · 0

    SIEMENS FILED MDR 1219913-2022-00274 INITIAL REPORT ON 2022-09-02. ADDITIONAL INFORMATION: 2022-11-30: SIEMENS PERFORMED AN ATELLICA IM VITAMIN B12 (VB12) STUDY USING INTERNAL MEDICAL DECISION POOL (MDP) CONTROLS AND BIO-RAD LYPHOCHEK CONTROLS. THE INTERNAL MDP CONTROLS AND BIO-RAD LYPHOCHEK CONTROLS RESULTED WITHIN RANGE. BIO-RAD LIQUICHEK CONTROLS WERE ALSO TESTED; LOT 85290 RECOVERED WITHIN ACCEPTABLE RANGES, BUT LOT 85310 RECOVERED HIGH OUT OF RANGE WITH THE LEVEL ONE (85311) CONTROL. THE SIEMENS INTERNAL STUDY DID NOT REPLICATE THE CUSTOMER OBSERVED FAILURES WITH MDPS, BIO-RAD LYPHOCHEK OR BIO-RAD LIQUICHEK LOT 85290, BUT DID REPLICATE THE CUSTOMER OBSERVED FAILURES WITH BIO-RAD LIQUICHEK LOT 85310. BIO-RAD UNITY DATA WAS REVIEWED AND SHOWED A CUMULATIVE RECOVERY OF LOT 85310 WAS HIGHER THAN THE TARGET VALUE FOR ALL THREE CONTROL LEVELS. SIEMENS REVIEWED PREVIOUS INTERNAL STUDIES FOR VB12 THAT USED FRESH DRAWN PATIENT SAMPLES. RESULTS INDICATED THAT THE QUALITY OF THE SPECIMEN COULD POTENTIALLY IMPACT THE PERFORMANCE OF THE ATELLICA IM VB12 ASSAY. CELLULAR DEBRIS COULD POTENTIALLY BE RESPONSIBLE FOR THE HIGHER THAN EXPECTED VB12 RESULTS. SIEMENS RECOMMENDS FOLLOWING ALL HANDLING INSTRUCTIONS PROVIDED BY THE SAMPLE COLLECTION TUBE MANUFACTURER. ADDITIONAL INFORMATION - 2022-12-06 SIEMENS CONCLUDED INVESTIGATION FOR AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER OBSERVATION OF DISCORDANT (ELEVATED) ATELLICA IM VITAMIN B12 (VB12) PATIENT RESULTS COMPARED TO LOWER RETEST RESULTS OBTAINED ON A DIFFERENT DAY WITH A DIFFERENT INSTRUMENT AND REAGENT LOT. THE PATIENTS WERE INITIALLY TESTED ON ANALYZER # IH00610 AND RETESTED ON ALTERNATE ATELLICA IM ANALYZER AT THE CUSTOMER SITE. THE PATIENT SAMPLES IN QUESTION ALL DEMONSTRATED A DECREASE IN RESULTS WHEN RETESTED ON A LATER DATE. UPON REVIEW OF THE COMPLAINT DATA, IT WAS NOTED THAT THE RETESTS OF THE PATIENT SAMPLES OCCURRED 3-4 DAYS LATER, AND TESTING WAS PERFORMED ON AN ALTERNATE REAGENT LOT. PER THE STORING THE SPECIMEN SECTION OF THE ATELLICA IM VB12 INSTRUCTIONS FOR USE (IFU), 10995437_EN REV. 02, 2019-08, PATIENT SAMPLES MUST BE FROZEN AT </= -20°CELSIUS IF NOT TESTED WITHIN 48 HOURS. THE CUSTOMER USES AN APTIO HIGH VOLUME SAMPLE REFRIGERATION SYSTEM FOR SAMPLE STORAGE AND THEREFORE SAMPLES WERE NOT FROZEN AND NOT ELIGIBLE FOR VB12 REPEATS PAST 48 HOURS. BIO-RAD QUALITY CONTROL (QC) LOT 85290 LEVELS 1-3 CUSTOMER RESULTS WERE SPORADICALLY OUT OF RANGE HIGH ACCORDING TO THE CUSTOMER RANGES DURING TIME OF PATIENT TESTING AND DAYS FOLLOWING. HOWEVER, ALL BIO-RAD QC MARKED AS OUT OF RANGE BY THE CUSTOMER WERE WITHIN BIO-RAD PACKAGE INSERT RANGES. THE QUALITY OF THE SPECIMEN COULD POTENTIALLY IMPACT THE PERFORMANCE OF THE ATELLICA IM VB12 ASSAY. CELLULAR DEBRIS COULD POTENTIALLY BE RESPONSIBLE FOR THE HIGHER THAN EXPECTED VB12 RESULTS. WHEN SAMPLES ARE CENTRIFUGED PRIOR TO TESTING AND REMAIN UPRIGHT OR ALLOWED TO SETTLE FOR AN EXTENDED PERIOD OF TIME, THE VB12 ASSAY CAN BE IMPACTED RESULTING IN LOWER VALUES. SIEMENS RECOMMENDS FOLLOWING ALL HANDLING INSTRUCTIONS PROVIDED BY THE SAMPLE COLLECTION TUBE MANUFACTURER. SIEMENS PERFORMED AN ATELLICA IM VB12 LOT 280 AND BIO-RAD QC LOT 85290, WHICH CONFIRMED THAT THIS LOT OF BIO-RAD QC IS PERFORMING AS EXPECTED AND WITHIN PUBLISHED PACKAGE INSERT RANGES AND CLOSE TO PACKAGE INSERT MEANS. QC AND REAGENT PERFORMANCE DURING STUDY SHOWED NO SIGNIFICANT DEGRADATION OVER A 4-DAY PERIOD ON 3 DIFFERENT PACKS OF VB12 LOT 280 REAGENT. SIEMENS CANNOT RULE OUT ISSUES WITH PRE-ANALYTICAL HANDLING OF PATIENT SAMPLES AS CAUSE OF PATIENT DISCORDANT RESULTS. BASED ON THE INVESTIGATION, NO PRODUCT PROBLEM WAS IDENTIFIED. THE CUSTOMER IS OPERATIONAL. IN SECTION H6, INVESTIGATION FINDING AND INVESTIGATION CONCLUSION CODES WERE UPDATED BASED ON THE INVESTIGATION RESULTS.

    Description of Event or Problem · 0

    THE CUSTOMER IDENTIFIED DISCORDANT (ELEVATED) VITAMIN B12 (VB12) PATIENT RESULTS ON ATELLICA IM 1600 INSTRUMENT # IH00610, REAGENT LOT 280 COMPARED TO LOWER RETEST RESULTS OBTAINED ON A DIFFERENT DAY WITH A DIFFERENT ATELLICA IM INSTRUMENT AND REAGENT LOT. THE CUSTOMER BELIEVES THE REPEAT RESULTS ARE CORRECT. THE INITIAL RESULTS WERE REPORTED TO PHYSICIAN(S) AND WERE QUESTIONED. CORRECTED REPORTS WERE ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT VB12 RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2367844 ATELLICA IM VITAMIN B12 (VB12) VITAMIN B12 IMMUNOASSAY CDD SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 280 00630414600284

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown