BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMEL

    MDR report key: 11674661 · Received April 15, 2021

    Report

    Report Number
    1924669-2021-00001
    Event Type
    Malfunction
    Date Received
    April 15, 2021
    Date of Event
    March 12, 2021
    Report Date
    April 15, 2021
    Manufacturer
    REMEL INC
    Product Code
    JSO
    UDI-DI
    00848838000546
    PMA / PMN Number
    K972359
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    RETAIN SAMPLES OF THE COMPLAINT LOT WERE SET AGAINST A COMPARISON LOT. THE REPORTED LOT, COMPARISON LOT, AND VIABILITY LOT PLATES WERE SET FOLLOWING THE INSPECTION PLAN PROCEDURE IN DUPLICATE WITH E. FAECALIS ATCC 29212 AND E. COLI ATCC 25922 USING A MCF 0.5 DILUTION AND E. FAECALIS ATCC 51299 USING A 1:100 DILUTION. A 10^-5 BACKTITER WAS SET FOR ALL VIABILITY PLATES. ALL THE PLATES WERE INCUBATED AT 33-37C IN AMBIENT ATMOSPHERE FOR 24 HOURS ON TOP OF THE PLATE RACK (PER IP). THE COMPLAINT WAS CONFIRMED AS COMPLAINT LOT HAD GOOD GROWTH WITH BLACKENING FOR E. FAECALIS ATCC 29212. A REVIEW OF THE BATCH RECORD WAS ALSO COMPLETED. FURTHER REVIEW INDICATED AN INCORRECT RAW MATERIAL WAS ADDED.

    Description of Event or Problem · 0

    CUSTOMER REPORTS BREAKTHROUGH GROWTH OF NEGATIVE QC STRAIN E. FAECALIS 29212 DURING QC TESTING. CUSTOMER STATES IT'S GROWING BETTER THAN THE POSITIVE STRAIN E. FAECALIS ATCC 51299 AND HAS THE BLACKENING. LOT NUMBER 237214 WAS SET UP SIDE BY SIDE WITH SAME BUG AND PERFORMED AS EXPECTED. LATER, THE CUSTOMER REPORTED THEY USED NEW CULTILOOP OF E.FAECALIS 29212 (LOT #929106 EXP 7/29/21). CUSTOMER PERFORMED RETEST QC USING 0.5 MCFARLAND OF THE QC ORGANISM ALONG WITH A 1:10 AND 1:100 DILUTION OF THE 0.5 MCFARLAND. ALL THREE FAILED QC. THE NEW LOT OF BILE ESCULIN AZIDE #255981 PASSED QC. NO PATIENT IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568196 REMEL BILE ESCULIN AZIDE AGAR W/6UG VANC JSO REMEL INC R01186 00848838000546

    Patients

    Seq Age Sex Outcome Treatment
    1