BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLINICAL CHEMISTRY CREATININE

    MDR report key: 3878532 · Received June 17, 2014

    Report

    Report Number
    1628664-2014-00116
    Event Type
    Injury
    Date Received
    June 17, 2014
    Date of Event
    April 17, 2014
    Report Date
    May 14, 2014
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    CGX
    PMA / PMN Number
    K981799
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT EVALUATION IS IN PROCESS AND THE RESULTS WILL BE SUBMITTED IN A FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 1

    THE SAMPLE THAT GAVE THE HIGH RESULT WAS RETURNED FOR ADDITIONAL TESTING. 5 REPLICATES OF THE SAMPLE WERE TESTED USING CREATININE REAGENT LOT 20666UN13, WITH RESULTS RANGING FROM 23.91 TO 24.22 MG/DL. INSTRUMENT LOG REVIEW WAS PERFORMED AND NO ISSUE WAS IDENTIFIED. A SEARCH FOR SIMILAR TICKETS WAS PERFORMED AND NO OTHER SIMILAR COMPLAINTS WERE FOUND. NO ADVERSE OR NON-STATISTICAL TRENDS WERE IDENTIFIED. NO MANUFACTURING ISSUE WAS FOUND FOR THE LOT IN QUESTION. LITERATURE SEARCHES WERE PERFORMED TO DETERMINE IF THERE ARE KNOWN INTERFERENCES WITH CREATININE LABORATORY TESTING WITH THE MEDICATIONS THE PATIENT WAS TAKING, KEPPRA, DIAZEPAM, TRICEF, DAFALGAM, AND ATROVENT. NO LITERATURE WAS FOUND THAT INDICATED THESE DRUGS CAUSE INTERFERENCE WITH CREATININE. ONE ARTICLE FROM THE (B)(4) DID NOTE THAT CEFIXIME (REPORTED AS AN INGREDIENT OF TRICEF IN PORTUGAL) CAN VERY RARELY CAUSE AN UNDESIRABLE EFFECT OF INCREASED BLOOD CREATININE. THE CREATININE REAGENT PACKAGE INSERT HAS ADEQUATE LABELING FOR REAGENT AND SAMPLE HANDLING AND STATES THAT INTERFERENCES FROM MEDICATIONS OR ENDOGENOUS SUBSTANCES MAY AFFECT RESULTS. THE OPERATIONS MANUAL HAS ADEQUATE TROUBLESHOOTING FOR ERRATIC RESULTS. THE RE-EVALUATION RESULTS DID NOT IDENTIFY A MALFUNCTION OR A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION WAS PERFORMED IN ORDER TO INVESTIGATE THIS ISSUE. A LOG REVIEW WAS UNABLE TO DETERMINE THE CAUSE OF THIS ISSUE. A SEARCH FOR SIMILAR TICKETS WAS PERFORMED AND NO OTHER SIMILAR COMPLAINTS WERE FOUND. NO ADVERSE OR NON-STATISTICAL TRENDS WERE IDENTIFIED. THE CREATININE REAGENT PACKAGE INSERT HAS ADEQUATE LABELING FOR REAGENT AND SAMPLE HANDLING AND STATES THAT INTERFERENCES FROM MEDICATIONS OR ENDOGENOUS SUBSTANCES MAY AFFECT RESULTS. THE OPERATIONS MANUAL HAS ADEQUATE TROUBLESHOOTING FOR ERRATIC RESULTS. THE CERTIFICATE OF ANALYSIS FOR CREATININE, LOT NUMBER 20666UN13, PASSED ALL RELEASE CRITERIA. BASED UPON THE DATA AVAILABLE AND THE RESULTS OF THIS INVESTIGATION, NO MALFUNCTION OR PRODUCT DEFICIENCY WAS IDENTIFIED TO BE RELATED TO THIS ISSUE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED ON JULY 29TH, INDICATED THAT WHILE IN THE ER, THE PATIENT WAS UNNECESSARILY ADMINISTERED SEVERAL MEDICATIONS INCLUDING ORAL ANTIBIOTICS (TRICEF) DUE TO THE DISCREPANT CREATININE RESULTS. NO FURTHER IMPACT TO PATIENT HEALTH WAS REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED DISCREPANT ARCHITECT CC CREATININE RESULTS. ONE PATIENT ((B)(6)) GENERATED A RESULT OF 25.83 MG/DL WHICH WAS REPEATED AT 25.81 AND 0.46 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354135 CLINICAL CHEMISTRY CREATININE CREATININE CGX ABBOTT MANUFACTURING INC 20666UN13

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ARCHITECT ANALYZER 01G06-11, SN (B)(4)| ARCHITECT ANALYZER 01G06-11, SN (B)(4)| ARCHITECT ANALYZER 01G06-11, SN (B)(4)