BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CREATININE PLUS VER.2

    MDR report key: 6033595 · Received October 17, 2016

    Report

    Report Number
    1823260-2016-01580
    Event Type
    Malfunction
    Date Received
    October 17, 2016
    Date of Event
    September 23, 2016
    Report Date
    February 7, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JFY
    PMA / PMN Number
    K024098
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED. BASED ON THE QC DATA, A GENERAL REAGENT OR CALIBRATOR ISSUE WAS NOT SUSPECTED. THE ROOT CAUSE COULD HAVE BEEN A TEMPORARY PREANALYTICAL ISSUE SUCH AS MATERIAL BUILD-UP ON THE SAMPLE PROBE. THERE WERE NO FURTHER OCCURRENCES REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER DISCOVERED QUESTIONABLE CREP2 CREATININE PLUS VER.2 RESULTS HAD BEEN GENERATED AFTER THE QC FAILED. AFTER THE QC WAS REPEATED AND FAILED AGAIN, CALIBRATION WAS PERFORMED. QC WAS REPEATED AND FAILED YET AGAIN. THE CUSTOMER PULLED FIVE PATIENT SAMPLES THAT HAD BEEN PREVIOUSLY TESTED, REPEATED THEM ON A DIFFERENT ANALYZER AND THE RESULTS WERE DISCREPANT. BASED ON THESE RESULTS, MORE PATIENT SAMPLES WERE RETESTED TO VERIFY THE RESULTS. CORRECTED REPORTS FOR 111 PATIENTS WERE PHONED TO DOCTOR'S OFFICES. OF THE DATA PROVIDED FOR 25 PATIENT SAMPLES, ONLY THE RESULTS FOR 20 SAMPLES WERE DISCREPANT. REFER TO THE ATTACHMENT TO THE MEDWATCH FOR ALL PATIENT DATA. ALL RESULTS ARE IN UMOL/L. NO PATIENTS WERE ADVERSELY AFFECTED. THE CUSTOMER USED COBAS C701 SERIAL NUMBER (B)(4). IT WAS FOUND THE ANALYZER HAD SWITCHED OVER TO A NEW REAGENT PACK IN THE EARLY AFTERNOON. BEFORE THE SWITCH OVER, QC RESULTS WERE GOOD. BASED ON THE QC DATA PROVIDED WHICH SHOWED SEVERAL ISSUES, THE INVESTIGATION DETERMINED IT WAS POSSIBLE THAT AN INDIVIDUAL REAGENT PACK WAS BAD DUE TO POSSIBLE IMPROPER STORAGE CONDITIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685820 CREATININE PLUS VER.2 ENZYMATIC METHOD, CREATININE JFY ROCHE DIAGNOSTICS NA 15403501

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR