BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS VITAMIN B12

    MDR report key: 19321015 · Received May 15, 2024

    Report

    Report Number
    9680746-2024-00001
    Event Type
    Injury
    Date Received
    May 15, 2024
    Date of Event
    January 23, 2024
    Report Date
    May 15, 2024
    Manufacturer
    BECKMAN COULTER IRELAND INC
    Product Code
    CDD
    PMA / PMN Number
    K223289
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1: THE FULL PATIENT IDENTIFIER IS CASE-(B)(4). THE NUMBER OF PATIENTS INVOLVED IN THIS EVENT WAS NOT PROVIDED. THE CUSTOMER DID NOT SUPPLY PATIENT DEMOGRAPHICS SUCH AS AGE, DATE OF BIRTH, SEX, WEIGHT, ETHNICITY OR RACE. MANUFACTURING DATE IS 01JAN2000 AS NO SPECIFIC NUMBER LOT WAS PROVIDED. ¿ NO ISSUES WITH SAMPLE INTEGRITY WERE REPORTED BY THE CUSTOMER. ¿ NO HARDWARE ERRORS OR OTHER ASSAY ISSUES WERE REPORTED IN CONJUNCTION WITH THIS EVENT. SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK, CALIBRATION AND QUALITY CONTROL WERE NOT PROVIDED FOR REVIEW. ¿ AN INTERNAL STUDY WAS PERFORMED IN ATTEMPT TO REPLICATE VARIABILITY AND 0 PG/ML RESULTS AT THE LOW END OF THE ASSAY RANGE (=100 PG/ML). THE STUDY DEMONSTRATED VITAMIN B12 CALIBRATOR RLU CAN VERY BETWEEN REAGENT PACKS AND WITHIN THE SAME REAGENT PACK CONTRIBUTING TO 0 PG/ML PATIENT RESULTS AND OVERALL LOW BIAS. ALTHOUGH DIFFERENCES WERE OBSERVED IN THE LOW END OF THE CALIBRATION CURVE, FIVE OF THE SIX REAGENT PACKS TESTED AS PART OF THE STUDY HAD S0 (STANDARD 0) AVERAGE RLU RECOVERY WITHIN VITAMIN B12 TECHNICAL PACK POST FILL SPECIFICATIONS OF 2.6-4.2 MILLION MEAN S0 RLU. ADDITIONALLY, ASSAY CALIBRATION PARAMETERS ARE DEFINED IN THE ASSAY PROTOCOL FILE (APF). NO CALIBRATION FAILURES WERE REPORTED AS PART OF THE STUDY. REVIEW OF COA (CERTIFICATES OF ANALYSIS) FOR REAGENT LOTS TESTED IN THE STUDY DEMONSTRATED THE PRODUCT MET RELEASE SPECIFICATIONS. ADDITIONALLY, THE IMPACT OF DIFFERENCES ON CALCULATED DOSE WAS REVIEWED AND FOUND TO NOT CHANGE THE RESULT INTERPRETATION. SAMPLES IN THE DEFICIENT RANGE WERE TESTED AS PART OF THE STUDY. THE MAJORITY OF SAMPLES TESTED HAD A CALCULATED DOSE RECOVERY BELOW THE VITAMIN B12 DEFICIENT RANGE OF =145 PG/ML, EVEN WHEN PACK RLU VARIABILITY WAS OBSERVED. ALTHOUGH 0 PG/ML RESULTS WERE REPLICATED WITH INTERNAL TESTING, VITAMIN B12 SAMPLES RECOVERING <50 PG/ML SHOULD BE REPORTED AS <50 PG/ML. ¿ THE ACCESS VITAMIN B12 REAGENT INSTRUCTIONS FOR USE (IFUS) LIMITATIONS SECTION STATES, ¿SAMPLES CAN BE ACCURATELY MEASURED WITHIN THE ANALYTICAL RANGE OF THE LOWER LIMIT OF DETECTION AND THE HIGHEST CALIBRATOR VALUE (APPROXIMATELY 50-1,500 PG/ML [37-1,107 PMOL/L]). IF A SAMPLE CONTAINS LESS THAN THE LOWER LIMIT OF DETECTION FOR THE ASSAY, REPORT THE RESULTS AS LESS THAN THAT VALUE (I.E., < 50 PG/ML [< 37 PMOL/L]).¿ ¿ ADDITIONALLY, PER THE VITAMIN B12 IFUS, PART NUMBER C64657 D, STATES ¿EACH LABORATORY SHOULD ESTABLISH ITS OWN REFERENCE RANGES TO ASSURE PROPER REPRESENTATION OF SPECIFIC POPULATIONS.¿ IN CONCLUSION, AN ASSIGNABLE CAUSE OF THE EVENT CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION. THERE IS INSUFFICIENT EVIDENCE TO SUGGEST A REAGENT OR HARDWARE MALFUNCTION OCCURRED IN THIS EVENT.

    Description of Event or Problem · 0

    ON 30APR2024 THE CUSTOMER REPORTED ERRONEOUSLY LOW VITAMIN B12 RESULTS (ACCESS VITAMIN B12, PART NUMBER 33000) WERE GENERATED ON THE CUSTOMER'S UNICEL DXI 800 ACCESS IMMUNOASSAY ANALYZERS (SERIAL NUMBERS (B)(6). THE EXACT NUMBER OF PATIENTS IMPACTED WAS NOT PROVIDED AND THERE IS NO SPECIFIC ACCESS VITAMIN B12 LOT NUMBERS INVOLVED IN THIS EVENT. THE CUSTOMER REPORTED THAT THE ACCESS RESULTS WERE DISCORDANT WITH THE ABBOTT METHODOLOGY. THE CUSTOMER PROVIDED ONLY TWO EXAMPLES OF DISCORDANT PATIENTS RESULTS FOR WHICH THE ACCESS RESULTS INDICATED ANEMIA BUT NOT THE ABBOTT ARCHITECT RESULTS. - PATIENT 1: ON 23JAN2024 THE ACCESS VITAMIN B12 WAS 115 NG/L. THE SAMPLE WAS REPEATED ON THE ABBOTT ARCHITECT ANALYZER ON 20APR2024 WITH A RESULT OF 261 NG/L. - PATIENT 2: ON 12FEB2024, ONE PATIENT SAMPLE GAVE A RESULT AT 99 NG/L AND WAS REPEATED ON THE ABBOTT ARCHITECT ANALYZER ON 20FEB2024 WITH A RESULT OF 246 NG/L. ACCESS VITAMIN B12 EXPECTED VALUES ARE 180 - 914 PG/ML. ABBOTT ARCHITECT EXPECTED VALUES ARE 187-883 NG/L. THE CUSTOMER REPORTED THAT SOME PATIENTS WERE TREATED BASED UPON THE ACCESS RESULTS THAT INDICATED ANEMIA. NO FURTHER INFORMATION WAS PROVIDED. AN EXTERNAL QUALITY ASSESSMENT (EQA) WAS PERFORMED AND THE GENERATED RESULTS WERE LOWER THAN THOSE GENERATED WITH COMPETITORS. NO HARDWARE ERRORS OR OTHER ASSAY ISSUES WERE REPORTED IN CONJUNCTION WITH THIS EVENT. SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK, CALIBRATION AND QUALITY CONTROL WERE NOT PROVIDED FOR REVIEW. NO ISSUES WITH SAMPLE INTEGRITY WERE REPORTED BY THE CUSTOMER. SAMPLE COLLECTION AND PROCESSING INFORMATION SUCH AS SAMPLE TYPE, VOLUME COLLECTED, SAMPLE CENTRIFUGATION TIME AND SPEED AND OTHER SAMPLE HANDLING INFORMATION WAS NOT PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469352 ACCESS VITAMIN B12 RADIOASSAY, VITAMIN B12 CDD BECKMAN COULTER IRELAND INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other