BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVATED ALANINE AMINOTRANSFERASE

    MDR report key: 12063140 · Received June 24, 2021

    Report

    Report Number
    3016438761-2021-00212
    Event Type
    Malfunction
    Date Received
    June 24, 2021
    Date of Event
    May 19, 2021
    Report Date
    June 24, 2021
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    CKA
    UDI-DI
    00380740017866
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    3016438761-06/14/21-001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ALL IN DATE LIST # AND LOT#S ARE LISTED AS BELOW. ACTIVATED ALANINE AMINOTRANSFERASE: LN 8L92-21- LOT 09153UN21, DOM 01APR2021/EXP 09MAR2022/UDI (B)(4). ACTIVATED ALANINE AMINOTRANSFERASE: LN 8L92-22- LOT 02954UN20, DOM 15SEP2020/EXP 29AUG2021/UDI (B)(4); LN 8L92-22- LOT 37921UN20, DOM 12JAN2021/EXP 01DEC2021/UDI (B)(4); LN 8L92-22- LOT 81823UN21, DOM 29MAR2021/EXP 16FEB2022 / UDI (B)(4). ACTIVATED ALANINE AMINOTRANSFERASE: LN 8L92-42- LOT 84126UN20, DOM 09JUL2020/ EXP 09JUL2021/UDI (B)(4); LN 8L92-42- LOT 03676UN20, DOM 25AUG2020/EXP 25AUG2021/UDI (B)(4); LN 8L92-42 - LOT 10597UN20, DOM 29AUG2020/EXP 29AUG2021/UDI (B)(4); LN 8L92-42- LOT 26275UN20, DOM 30NOV2020/EXP 20OCT2021/UDI (B)(4); LN 8L92-42- LOT 77748UN20, DOM 09MAR2021/EXP 08DEC2021/UDI (B)(4); LN 8L92-42- LOT 65958UN20, DOM 05FEB2021/EXP 08DEC2021/UDI (B)(4); LN 8L92-42- LOT 81824UN21, DOM 29MAR2021/EXP 16FEB2022/UDI (B)(4). ALINITY C ACTIVATED ALANINE AMINOTRANSFERASE: LN 8P18-20- LOT 83459UN20, DOM 09JUL2020/EXP 09JUL2021/UDI (B)(4). LN 8P18-20- LOT 03168UN20, DOM 25SEP2020/EXP 25SEP2021/UDI (B)(4); LN 8P18-20- LOT 09787UN20, DOM 25SEP2020/EXP 24OCT2021/UDI (B)(4); LN 8P18-20- LOT 37977UN20, DOM 01JAN2021/EXP 01JAN2022/UDI(B)(4); LN 8P18-20- LOT 63000UN20, DOM 01JAN2021/EXP 01JAN2022/UDI (B)(4); LN 8P18-20- LOT 77745UN20, DOM 28JAN2021/EXP 08JAN2022/UDI (B)(4); LN 8P18-20- LOT 77743UN21, DOM 18MAR2021/EXP 02MAR2022/UDI (B)(4); LN 8P18-20- LOT 09237UN21, DOM 24APR2021/EXP 09APR2022/UDI (B)(4). CORRECTION/REMOVAL NUMBER: 3016438761-06/14/21-001-C. A PRODUCT CORRECTION LETTER WAS SENT TO ALL CUSTOMERS WHO HAVE RECEIVED IN-DATE LOTS OF THE ARCHITECT A-ALT REAGENT (LIST 8L92-21, 8L92-22, AND 8L92-42) AND ALINITY C A-ALT REAGENT (08P18-20). THE LETTER INFORMS THE CUSTOMER OF THE ISSUES AND PROVIDES INSTRUCTIONS WITH THE NECESSARY ACTIONS TO PERFORM WHICH INCLUDES IMMEDIATELY INSTALLING THE APPROPRIATE A-ALT ASSAY FILE (VERSION 7 FOR ALINITY AND VERSION 10 FOR ARCHITECT) AND MANUALLY CONFIGURING THE HIGH LINEARITY ASSAY PARAMETER TO 1200 U/L. TO ADDRESS THE LINEARITY ISSUE, NEW A-ALT ASSAY FILE VERSIONS 7 (ALINITY) AND VERSIONS 10 (ARCHITECT) HAVE BEEN RELEASED WITH AN UPDATED HIGH-LINEARITY VALUE OF 1,200 U/L (FROM 4772 U/L) TO PREVENT THE POTENTIAL FOR INCORRECT RESULTS. ADDITIONALLY, TO ADDRESS THE INTERFERENCE ISSUE, THE ACTIVATED ALANINE AMINOTRANSFERASE REAGENT INSTRUCTIONS FOR USE (IFU) WILL BE UPDATED WITH THE LINEARITY RANGE REDUCTION AND THE NEW BILIRUBIN INTERFERENCE INFORMATION. UNTIL THE IFU IS UPDATED, ALL A-ALT REAGENT KITS WILL INCLUDE LABELING WITH THIS REVISED INFORMATION.

    Description of Event or Problem · 0

    ABBOTT IDENTIFIED INTERNALLY THAT THE ACTIVATED ALANINE AMINOTRANSFERASE (A-ALT) LINEARITY SPECIFICATION WAS NOT BEING MET WHEN USING A-ALT REAGENT (LN 08L92) AS IT NEARS EXPIRATION ON THE ARCHITECT. THERE IS A POTENTIAL FOR > 10% UNDER-RECOVERY ON A-ALT SAMPLES GREATER THAN 1,200 U/L. ADDITIONALLY, IT WAS IDENTIFIED THAT THE ARCHITECT (LN 08L92) AND ALINITY C (LN 08P18) A-ALT ASSAYS WERE NOT MEETING BILIRUBIN INTERFERENCE CLAIMS WITH SAMPLES CONTAINING BILIRUBIN CONCENTRATIONS GREATER THAN 31 MG/DL. INTERNAL INTERFERENCE TESTING DEMONSTRATED A 10% SHIFT IN PATIENT RESULTS WITH SAMPLES CONTAINING BILIRUBIN CONCENTRATIONS GREATER THAN 31 MG/DL. THERE HAS BEEN NO REPORTED DELAY IN RESULTS OR PATIENT HARM AS A RESULT OF EITHER OF THESE ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    961117 ACTIVATED ALANINE AMINOTRANSFERASE NADH OXIDATION/NAD REDUCTION, ALT/SGPT CKA ABBOTT LABORATORIES 8L92-21 15014UN20 00380740017866

    Patients

    Seq Age Sex Outcome Treatment
    1 ALINITY C PROCESSING MODULE, LN 03R67-01| ARC C16K PRC MOD, LIST # 3L77| ARC C4000 PRC MOD, LIST# 2P24, 1R24, 1R25| ARC C8000 PRC MOD, LIST # 1G06