BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT BNP CALIBRATORS

    MDR report key: 8683703 · Received June 10, 2019

    Report

    Report Number
    3002809144-2019-00298
    Event Type
    Malfunction
    Date Received
    June 10, 2019
    Date of Event
    December 13, 2018
    Report Date
    June 10, 2019
    Manufacturer
    ABBOTT GERMANY
    Product Code
    JIT
    UDI-DI
    00380740145255
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    3002809144-06/4/19-006R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION/REMOVAL NUMBER: 3002809144-06/4/19-006-R. A PRODUCT RECALL LETTER WAS ISSUED TO ALL ARCHITECT BNP CUSTOMERS WHO HAVE RECEIVED CALIBRATOR OR CONTROL LOTS STILL WITHIN DATING. THE LETTER INFORMS THE CUSTOMER OF THE ISSUE REGARDING A TIME DEPENDENT STABILITY ISSUE OF THE ARCHITECT BNP CALIBRATORS AND CONTROLS THAT MAY LEAD TO CONTROLS OUT OF RANGE AND SHIFT IN CONTROL AND PATIENT RESULTS. THE LETTER INFORMS THE CUSTOMER ALL ARCHITECT BNP CALIBRATORS AND CONTROLS WILL HAVE SHORTENED EXPIRATION DATES OF 165 DAYS FROM THE DATE OF MANUFACTURE. THE LETTER INSTRUCTS THE CUSTOMER TO DISCONTINUE USE OF THE LOTS WHICH ARE BEYOND THE 165 DAY EXPIRATION AND DESTROY ANY REMAINING INVENTORY. THE CAUSE OF THE SHIFT IS INSTABILITY OF THE ARCHITECT BNP CALIBRATORS AND CONTROLS. THIS RECALL INCLUDES THE FOLLOWING PRODUCTS: SUSPECT MEDICAL DEVICES AND MANUFACTURE DATES: BRAND NAME: ARCHITECT BNP CALIBRATORS; COMMON DEVICE NAME: BNP CALIBRATORS; PRODUCT CODE JIT; CATALOG # 08K28-03; UDI # (B)(4): LOT 44K79418, MANUFACTURE DATE 07/23/2018, EXPIRATION 07/23/2019; LOT 44K81018, MANUFACTURE DATE 09/05/2018, EXPIRATION 09/05/2019; LOT 44K82018, MANUFACTURE DATE 10/09/2018, EXPIRATION 10/09/2019; LOT 44K85219, MANUFACTURE DATE 01/22/2019, EXPIRATION 01/22/2020. BRAND NAME: ARCHITECT BNP CALIBRATORS; COMMON DEVICE NAME: BNP CALIBRATORS; PRODUCT CODE N/A; CATALOG # 08K28-09; LOT 44K84119, MANUFACTURE DATE 12/17/2018, EXPIRATION 12/17/2019. BRAND NAME: ARCHITECT BNP CONTROLS; COMMON DEVICE NAME: BNP CONTROLS; PRODUCT CODE JJX; CATALOG # 08K28-12; UDI # (B)(4): LOT 44K79518 MANUFACTURE DATE 07/23/2018, EXPIRATION 07/23/2019; LOT 44K81118 MANUFACTURE DATE 09/05/2018, EXPIRATION 09/05/2019; LOT 44K82818 MANUFACTURE DATE 11/15/2018, EXPIRATION 11/15/2019 LOT 44K84219 MANUFACTURE DATE 12/17/2018, EXPIRATION 12/17/2019.

    Description of Event or Problem · 1

    ABBOTT LABORATORIES HAS CONFIRMED THE ARCHITECT BNP CALIBRATORS LN 08K28-03 AND 08K28-09 AND CONTROLS LN 08K28-12 DEMONSTRATE AN AGE DEPENDENT SHIFT IN PERFORMANCE. THIS SHIFT CAN CAUSE FALSELY ELEVATED PATIENT AND/OR CONTROL RESULTS ON THE ARCHITECT BNP ASSAY LN 08K28 WHEN USING THE IMPACTED CALIBRATORS. ADDITIONALLY, USE OF IMPACTED CONTROLS MAY RESULT IN INVALID PATIENT RESULTS DUE TO CONTROLS OUT OF RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475032 ARCHITECT BNP CALIBRATORS BNP CALIBRATORS JIT ABBOTT GERMANY 44K79418 00380740145255

    Patients

    Seq Age Sex Outcome Treatment
    1