BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BROMELIN FOR ERYTYPE, 10 ML

    MDR report key: 6747023 · Received July 27, 2017

    Report

    Report Number
    9610824-2017-00049
    Event Type
    Malfunction
    Date Received
    July 27, 2017
    Date of Event
    June 29, 2017
    Report Date
    August 11, 2017
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    UDI-DI
    07611969965755
    PMA / PMN Number
    BK040070
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS OUR FINAL REPORT ON THIS INCIDENT.

    Additional Manufacturer Narrative · 1

    THIS IS OUR INITIAL REPORT ON THIS INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A DISCREPANCY WHEN TYPING ON TWO TANGO OPTIMO INSTRUMENTS. RH NEGATIVE SAMPLES WERE BEING READ AS POSITIVE. THE CUSTOMER SUSPECTED THE BROMELIN FOR ERYTYPE TO BE THE CAUSE FOR THE FALSE POSITIVE RESULTS. THE CUSTOMER SENT BACK THE ALLEGEDLY DEFECTIVE PRODUCT BROMELIN FOR ERYTYPE FOR INVESTIGATIONAL TESTING BUT AT THE TIME THE ALLEGEDLY DEFECTIVE PRODUCT ARRIVED AT BMD IT WAS ALREADY EXPIRED, WAS CONTAMINATED AND EVEN MOULDY. THEREFORE OUR QUALITY CONTROL LABORATOY TESTED THEIR RETAINED SAMPLE BROMELIN FOR ERYTYPE, #8701110-00. THE ERYTYPE S ABD+REV. A1B #8646110, THAT WAS USED BY THE CUSTOMER, WAS ALSO USED IN THIS TEST. 12 SAMPLES WERE TESTED AND ALL REACTIONS WERE AS EXPECTED. WE DID NOT OBSERVE ANY FALSE POSITIVE REACTION. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVE INFLUENCES ON THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT OF BROMELIN FOR ERYTYPE. BOTH AFFECTED TANGO OPTIMO WERE INSPECTED BY OUR FIELD SERVICE ENGINEER WITH NO INDICATION FOR A MALFUNCTION. BOTH INSTRUMENTS ARE WORKING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ABOUT UNEXPECTED POSITIVE RESULTS OF KNOWN RH D NEGATIVE SAMPLES BY ERYTYPE S ABD+REV A1,B ON HIS BOTH TANGO OPTIMO INSTRUMENTS. THE CUSTOMER WAS SUSPECTING THAT THE BROMELIN FOR ERYTYPE+ERYTYPE S (LOT # 8701110-00) COULD BE THE CAUSE FOR THE FALSE POSITIVE RESULTS AND RETURNED THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING. BUT ON DATE OF RECEIPT ((B)(6)2017) THE COMPLAINT MATERIAL WAS ALREADY EXPIRED (EXP.: 07/04/2017). OUR QUALITY CONTROL IS PLANNING FURTHER TESTING, THE INVESTIGATIONS ARE ONGOING. BOTH AFFECTED TANGO OPTIMO INSTRUMENTS WERE INSPECTED BY ONE OF OUR FIELD SERVICE ENGINEERS WITH NO INDICATION FOR AN INSTRUMENT MALFUNCTION. THE INSTRUMENTS WERE CONFIRMED TO OPERATE WITHIN SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526953 BROMELIN FOR ERYTYPE, 10 ML BROMELIN FOR ERYTYPE KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH 8701110-00 07611969965755

    Patients

    Seq Age Sex Outcome Treatment
    1