BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C-PEPTIDE REAGENT

    MDR report key: 2165565 · Received July 17, 2011

    Report

    Report Number
    1415939-2011-00515
    Event Type
    Malfunction
    Date Received
    July 17, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 11, 2011
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JKD
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    1415939-7/11/11-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    SUSPECT MEDICAL DEVICE, LOT #: ADDITIONAL SUSPECT LOTS: 01711A000, MANUFACTURE DATE: (B)(4) 2011, EXPIRATION DATE: 12/12/11, (B)(4), MANUFACTURE DATE: (B)(4) 2011, EXPIRATION DATE: 10/29/11, (B)(4), MANUFACTURE DATE: (B)(4) 11, EXPIRATION DATE: 1/10/12, (B)(4), MANUFACTURE DATE: (B)(4) 2011, EXPIRATION DATE: 4/16/12. PATIENT: NO CONSEQUENCES OR IMPACT TO PATIENT (B)(4); (B)(4). DEVICE: HIGH TEST RESULTS (B)(4); (B)(4) THE CAUSE OF THE ARCHITECT C-PEPTIDE FALSELY ELEVATED QUALITY CONTROL AND PATIENT RESULTS WAS DUE TO A NEW ANTIBODY LOT USED IN THE MANUFACTURING OF THE C-PEPTIDE MICROPARTICLE AND/OR CONJUGATE REAGENTS. ABBOTT ISSUED A PRODUCT RECALL LETTER TO ALL CUSTOMERS WITH INSTRUCTIONS TO DISCARD AND DESTROY ANY REMAINING INVENTORY OF THE AFFECTED LOTS.

    Description of Event or Problem · 1

    THE ARCHITECT C-PEPTIDE ASSAY IS A CHEMILUMINESCENT MICROPARTICLE ASSAY FOR THE QUANTITATIVE DETERMINATION OF C-PEPTIDE IN HUMAN SERUM, PLASMA AND URINE AND IS USED AS AN AID IN THE DIAGNOSIS AND TREATMENT OF PATIENTS WITH ABNORMAL INSULIN SECRETION INCLUDING DIABETES MELLITUS. DURING A COMPLAINT INVESTIGATION, A PRODUCT DEFICIENCY WAS IDENTIFIED FOR ARCHITECT C-PEPTIDE REAGENTS, LIST # 3L53-25, LOTS 03610K000 AND 01711A000, WHICH HAVE THE POTENTIAL TO GENERATE FALSELY ELEVATED RESULTS WITH CERTAIN PATIENT SAMPLES AND NON-ABBOTT QUALITY CONTROLS. ABBOTT CONTROLS DO NOT EXHIBIT THIS SHIFT. A PRODUCT RECALL WAS ISSUED AND REPORTED UNDER 21CFR806 FOR THE ARCHITECT C-PEPTIDE REAGENT TO THE (B)(4) DISTRICT ON (B)(4) 2011. ABBOTT HAS NOT RECEIVED ANY REPORTS OF ADVERSE EVENTS RELATED TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT C-PEPTIDE REAGENT JKD ABBOTT LABORATORIES 03610K000

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT ISYSTEM ANALYZERS| ARCHITECT ISYSTEM ANALYZERS