BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHROMID® CPS ELITE

    MDR report key: 8034463 · Received November 2, 2018

    Report

    Report Number
    3002769706-2018-00229
    Event Type
    Malfunction
    Date Received
    November 2, 2018
    Report Date
    December 11, 2018
    Manufacturer
    BIOMERIEUX S.A.
    Product Code
    JXA
    UDI-DI
    03573026443900
    PMA / PMN Number
    C1 EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTERNAL INVESTIGATION WAS PERFORMED DUE TO A NO RESULT (NO GROWTH) FOR AN EXTERNAL QUALITY CONTROL (EQA) SAMPLE (NEQAS DISTRIBUTION 4341 SAMPLE 4569) ON CHROMID® CPS ELITE (CPSE) AGAR. LOT NUMBER RECORD ANALYSIS: QC RECORDS CONFIRMED THAT LOTS 1006606560 AND 100666680 MET ALL SPECIFICATIONS PRIOR TO PRODUCT RELEASE, TAKE INTO CONSIDERATION THAT S.SAPROPHYTICUS IS NOT TESTED ON A ROUTINE BASES. NON-CONFORMITIES AND DEVIATIONS WERE NOT RECORDED ON THIS LOT NUMBER. RETAINED SAMPLE ANALYSIS: IN ORDER TO CHECK IF THE MEDIUM HAS STILL THE SAME PERFORMANCE, TWO STAPHYLOCOCCUS SAPROPHYTICUS (INTERNAL ATTC 15305 STRAIN AND NEQAS CUSTOMER STRAIN) WERE STREAKED ON : ONE FRESH CHROMID CPSE, IN ORDER TO DEMONSTRATE IIF ALONG THE SHELF LIFE OF THE PRODUCT THE SENSITIVITY COULD CHANGE. BOTH CHROMID CPSE BATCHES COMPLAINED ( 1006606560 AND 100666680). TWO CHROMID CPSE BATCHES WITH THE SAME EXPIRED THAT THAN BOTH BATCHES COMPLAINED PLATES WERE INCUBATED AT 33-37ºC AND INCUBATED UP TO 20-28 HOURS. ALL CHROMID CPSE SHOWED AN OPTIMAL PERFORMANCE REGARDING SENSITIVITY FOR THEIR ABILITY TO SUPPORT THE GROWTH OF BOTH S. SAPROPHYTICUS. THE BATCHES MET REQUIREMENTS REGARDING PERFORMANCE SPECIFICATIONS, AND BOTH STRAINS WERE ABLE TO GROW. COMPLAINT TREND ANALYSIS: A REVIEW OF COMPLAINTS REGISTERED FOR BOTH IMPACTED BATCHES 1006666680 AND 1006606560 DID NOT INDICATE ANY SYSTEMIC TREND. STATISTICAL TREND ANALYSIS WAS PERFORMED FOR THIS PRODUCT (JAN2016 -OCT2018), AND DID NOT SHOW ANY SIGNIFICANT ISSUE. CONCLUSION: CHROMID CPS ELITE PERFORMED AS EXPECTED.

    Description of Event or Problem · 1

    A CUSTOMER IN THE (B)(6) REPORTED A FALSE NEGATIVE (NO GROWTH) RESULT FOR A NEQAS SURVEY SAMPLE ((B)(6)), WHEN USING THE CHROMID® CPS ELITE AGAR (LOT1006666680). THE EXPECTED RESULT OF THE NEQAS SAMPLE WAS STAPHYLOCOCCUS SAPROPHYTICUS. THE CUSTOMER TESTED A NEW SAMPLE ON THE SAME LOT OF CHROMID CPS ELITE AND ON COLUMBIA BLOOD AGAR. THE ISOLATE GREW WELL ON THE COLUMBIA BLOOD AGAR, BUT HAD NO GROWTH ON THE CHROMID CPS ELITE. THE CUSTOMER RECEIVED A NEW SAMPLE ((B)(6)) FROM NEQAS AND TESTED IT ON THE CHROMID CPS ELITE, AND THE RESULT WAS NO GROWTH. THERE WAS NO PATIENT INVOLVEMENT AS THE EVENT PERTAINED TO A SURVEY SAMPLE. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    873835 CHROMID® CPS ELITE CHROMID® CPS ELITE JXA BIOMERIEUX S.A. 1006706520 03573026443900

    Patients

    Seq Age Sex Outcome Treatment
    1