BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINICAL CHEMISTRY CALCIUM

    MDR report key: 2498009 · Received March 21, 2012

    Report

    Report Number
    1628664-2012-00165
    Event Type
    Malfunction
    Date Received
    March 21, 2012
    Report Date
    February 26, 2012
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    CJY
    PMA / PMN Number
    K981578
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER OBSERVATION OF ELEVATED CLINICAL CHEMISTRY PATIENT RESULT APPEARS TO BE SPECIFIC TO THE PATIENT SAMPLE IN QUESTION. THE PATIENT WAS AWAITING BIOPSY OF ABDOMINAL MASS; HAD ANEMIA AND RENAL FAILURE. THE PATIENT SAMPLE WAS NOT AVAILABLE FOR EVALUATION BY ABBOTT. THE CERTIFICATE OF ANALYSIS FOR CLINICAL CHEMISTRY CALCIUM REAGENT LN 03L79-21 INDICATED LOT 44898UN11 MET RELEASE SPECIFICATIONS. NO ADVERSE OR NON-STATISTICAL TRENDS WERE IDENTIFIED FOR CLINICAL CHEMISTRY CALCIUM REAGENT LN 03L79-21 OVER THE LAST 12 MONTHS. A REVIEW OF ALL COMPLAINTS ASSOCIATED WITH CLINICAL CHEMISTRY CALCIUM REAGENT LOT 44898UN11 DID NOT IDENTIFY SIMILAR COMPLAINTS. ARCHITECT SYSTEM OPERATIONS MANUAL AND CLINICAL CALCIUM PACKAGE INSERT FOR LN 3L79-21 ADDRESS PROBABLE CAUSES AND CORRECTIVE ACTIONS ASSOCIATED WITH REAGENT AND SAMPLE HANDLING AND INTEGRITY. BASED ON THE AVAILABLE INFORMATION, NO DEFICIENCY OF CALCIUM REAGENT LN 03L79-21, LOT 44898UN11 WAS IDENTIFIED. IN CONCLUSION, OUR EVALUATION INDICATES CLINICAL CHEMISTRY CALCIUM REAGENT LN 03L79-21 LOT 44898UN11 IS PERFORMING AS EXPECTED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED AN ELEVATED CLINICAL CHEMISTRY CALCIUM RESULT WAS GENERATED AND FLAGGED HIGH FOR ONE PATIENT SAMPLE (NO VALUE PROVIDED) WHEN REAGENT LOT 44898UN11 WAS IN USE. REPEAT ARCHITECT TESTING GENERATED VARYING RESULTS BETWEEN 3.5 AND 4.65 MMOL/L. THE SAMPLE WAS SENT TO ANOTHER LAB AND A RESULT OF 3.45 MMOL/L WAS GENERATED MULTIPLE TIMES WITH THE ROCHE ASSAY, THEREFORE, THE ARCHITECT RESULT OF 3.5 MMOL/L WAS REPORTED. THE QUALITY CONTROLS WERE WITHIN SPECIFICATIONS AND ALL OTHER PATIENT RESULTS WERE SATISFACTORY. THE CUSTOMER REVIEWED THE ARCHITECT REACTION GRAPHS (DURING THE READ WINDOW) FOR VARIABILITY AND NOTED THE OPTICAL DENSITY INCREASED FOR SOME TESTS WHILE OTHERS DID NOT. THE INITIAL UNKNOWN ELEVATED RESULT WAS NOT REPORTED OUT OF THE LAB, THEREFORE, THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINICAL CHEMISTRY CALCIUM CJY ABBOTT MANUFACTURING INC 44898UN11

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR ARCHITECT C8000, LIST #1G06-01, SN (B)(4)| ARCHITECT C8000, LIST # 1G06-01, SN (B)(4)