BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1415939-2019-00031

    MDR report key: 8683680 · Received June 10, 2019

    Report

    Report Number
    1415939-2019-00031
    Event Type
    Malfunction
    Date Received
    June 10, 2019
    Date of Event
    December 13, 2018
    Report Date
    June 10, 2019
    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 FOR SUSPECT MEDICAL DEVICE AND MANUFACTURE DATE: BRAND NAME: ARCHITECT BNP CALIBRATORS; COMMON DEVICE NAME: BNP CALIBRATORS; PRODUCT CODE JIT; CATALOG # 08K28-02; UDI # (B)(4). LOT 44K79318, MANUFACTURE DATE 07/23/2018, EXPIRATION 07/23/2019; LOT 44K80818, MANUFACTURE DATE 09/05/2018, EXPIRATION 09/05/2019; LOT 44K82118, MANUFACTURE DATE 10/09/2018, EXPIRATION 10/09/2019; LOT 44K82618, MANUFACTURE DATE 11/15/2018, EXPIRATION 11/15/2019; LOT 44K85119, MANUFACTURE DATE 01/22/2019, EXPIRATION 01/22/2020. BRAND NAME: ARCHITECT BNP CONTROLS; COMMON DEVICE NAME: BNP CONTROLS; PRODUCT CODE JJX; CATALOG # 08K28-11; UDI # 00380740017477: LOT 44K78918 MANUFACTURE DATE 06/18/2018, EXPIRATION 06/18/2019; LOT 44K80918 MANUFACTURE DATE 09/05/2018, EXPIRATION 09/05/2019; LOT 44K82718 MANUFACTURE DATE 11/15/2018, EXPIRATION 11/15/2019.

    Description of Event or Problem · 1

    ABBOTT LABORATORIES HAS CONFIRMED THE ARCHITECT BNP CALIBRATORS LN 08K28-02 AND CONTROLS LN 08K28-11 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.

    Patients

    Seq Age Sex Outcome Treatment
    1