BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C HEMOGLOBIN A1C REAGENT KIT

    MDR report key: 14843108 · Received June 28, 2022

    Report

    Report Number
    3016438761-2022-00284
    Event Type
    Malfunction
    Date Received
    June 28, 2022
    Date of Event
    May 2, 2022
    Report Date
    June 28, 2022
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    PDJ
    UDI-DI
    00380740135591
    PMA / PMN Number
    K130255
    Removal / Correction Number
    3016438761-06/16/22-001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT IDENTIFIER AND DATE OF EVENT: (B)(6) 2022: SAMPLE IDS (B)(6). (B)(6) 2022: SAMPLE IDS (B)(6). (B)(6) 2022: SAMPLE IDS (B)(6). (B)(6) 2022: SAMPLE IDS (B)(6). (B)(6) 2022: SAMPLE IDS (B)(6). CORRECTION/REMOVAL REPORTING NUMBER: 3016438761-06/16/22-001-C. DURING THE INVESTIGATION TO THIS ISSUE, INTERNAL DATA ANALYSIS FOUND THE CURRENT SET VALUE FOR LOW LINEARITY RANGE FOR THE TOTAL HEMOGLOBIN IS TOO LOW WHEN ANALYZING WHOLE BLOOD OR HEMOLYSATE SAMPLES WITH POOR SAMPLE INTEGRITY, DUE TO MICRO-CLOTS AND PARTICULATE MATTER, ASSOCIATED WITH LOW TOTAL HEMOGLOBIN VALUES. IT WAS IDENTIFIED THAT A REVISION TO THE TOTAL HEMOGLOBIN LOW LINEARITY VALUES FOR THE ALINITY HEMOGLOBIN A1C WHOLE BLOOD AND HEMOLYSATE APPLICATIONS WAS REQUIRED. TO ADDRESS THE LINEARITY ISSUE, FOR WHOLE BLOOD APPLICATION, THE THBWB LOW LINEARITY VALUE HAS BEEN UPDATED TO 53.8278 UMOL/L; FOR THE HEMOLYSATE APPLICATION, THE THBH LOW LINEARITY VALUE HAS BEEN UPDATED TO 1250 UMOL/L TO PREVENT THE POTENTIAL FOR FALSELY ELEVATED RESULTS. A PRODUCT CORRECTION LETTER WAS SENT TO ALL CUSTOMERS WHO HAVE RECEIVED IMPACTED LOTS OF THE ALINITY C HEMOGLOBIN A1C REAGENT KIT (LIST NUMBER 08P4320). THE LETTER INFORMS THE CUSTOMER OF THE ISSUE AND PROVIDES THEM WITH INSTRUCTIONS FOR NECESSARY ACTIONS TO PERFORM, WHICH INCLUDES IMMEDIATELY INSTALLING THE UPDATED ASSAY FILE VERSIONS (BASED ON THEIR IMPACTED PRODUCT AND SAMPLE APPLICATION) AND THEN MANUALLY CONFIGURING THE LOW LINEARITY VALUE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED DISCREPANT ALINITY C HEMOGLOBIN A1C RESULTS ON MULTIPLE PATIENT SAMPLES THAT WERE NORMAL UPON REPEAT ON THE ALINITY ANALYZER AND VARIANT (HPLC). THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2022. SID (B)(6) INITIAL %HBA1C RESULT = > 14.0%, REPEAT = 5.70%, VARIANT (HPLC) = 6.20%, SID (B)(6) INITIAL %HBA1C RESULT = > 14.0 %, REPEAT = 7.90%, VARIANT (HPLC) = 9.30%, SID (B)(6) INITIAL %HBA1C RESULT = > 14.0%, REPEAT = 7.40%, VARIANT (HPLC) = 4.50%, SID (B)(6) INITIAL %HBA1C RESULT = > 14.0%, REPEAT = 6.90%, VARIANT (HPLC) = 7.10%. (B)(6) 2022. SID (B)(6) INITIAL %HBA1C RESULT = > 14.0%, REPEAT = > 14%, VARIANT (HPLC) = 4.20%, SID (B)(6) INITIAL %HBA1C RESULT = > 14.0%, REPEAT = 5.60%, VARIANT (HPLC) = 6.00%, SID (B)(6) INITIAL %HBA1C RESULT = > 14.0%, REPEAT = 6.20%, VARIANT (HPLC) = 6.20%. (B)(6) 2022 . SID (B)(6) INITIAL %HBA1C RESULT = > 14.0%, REPEAT = 6.00%, VARIANT (HPLC) = 6.40%, SID (B)(6) INITIAL %HBA1C RESULT = > 14.0%, REPEAT = 8.00%, VARIANT (HPLC) = 7.80%, SID (B)(6) INITIAL %HBA1C RESULT = > 14.0%, REPEAT = 7.30%, VARIANT (HPLC) = 7.40%, SID (B)(6) INITIAL %HBA1C RESULT = > 14.0%, REPEAT = 6.60%, VARIANT (HPLC) = 6.60%, SID (B)(6) INITIAL %HBA1C RESULT = > 14.0%, REPEAT = 6.30%, VARIANT (HPLC) = 6.30%, SID (B)(6) INITIAL %HBA1C RESULT = > 14.0%, REPEAT = 10.30%, VARIANT (HPLC) = 10.20%, SID (B)(6) INITIAL %HBA1C RESULT = > 14.0%, REPEAT = 6.00%, VARIANT (HPLC) = 6.40%, SID (B)(6) INITIAL %HBA1C RESULT = > 14.0%, REPEAT = 8.00%, VARIANT (HPLC) = 7.80%, SID (B)(6) INITIAL %HBA1C RESULT = > 14.0%, REPEAT = 8.50%, VARIANT (HPLC) = 8.50%. (B)(6) 2022. (B)(6) INITIAL %HBA1C RESULT = > 14.0%, REPEAT = 5.30%, VARIANT (HPLC) = 5.50%, (B)(6) INITIAL % HBA1C RESULT = > 14.0%, REPEAT = 5.70%, VARIANT (HPLC) = 6.00%, (B)(6) INITIAL %HBA1C RESULT = > 14.0%, REPEAT = 4.80%, VARIANT (HPLC) = 4.80%, (B)(6) INITIAL %HBA1C RESULT = > 14.0%, REPEAT = 7.70%, VARIANT (HPLC) = 7.50%, (B)(6) INITIAL %HBA1C RESULT = > 14.0%, REPEAT = 5.00%, VARIANT (HPLC) = 5.10%. (B)(6) 2022. SID (B)(6) %HBA1C RESULT = > 14.0%, SID (B)(6) %HBA1C RESULT = > 14.0%. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1813758 ALINITY C HEMOGLOBIN A1C REAGENT KIT HEMOGLOBIN A1C TEST SYSTEM PDJ ABBOTT LABORATORIES 08P4320 60540UQ09 00380740135591

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ALNTY C PROCESSING MODU, 03R67-01, AC02593