BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAGENT RED BLOOD CELLS BIOTESTCELL 1&2

    MDR report key: 6192518 · Received December 21, 2016

    Report

    Report Number
    9610824-2016-00088
    Event Type
    Malfunction
    Date Received
    December 21, 2016
    Date of Event
    November 25, 2016
    Report Date
    January 16, 2017
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    UDI-DI
    07611969952380
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 THAT AN ANTI-FY(A) WAS MISSED DURING TESTING WITH BIOTESTCELL 1&2 ON TANGO OPTIMO. THE CUSTOMER REPORTED THAT THE PATIENT SAMPLE SHOWED A (B)(6) RESULT IN THE FIRST RUN ON TANGO OPTIMO. BUT WHEN THE SCREENING TEST WAS REPEATED ON TANGO OPTIMO, IT WAS NEGATIVE. THE CUSTOMER RETURNED THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING AND ALSO TWO PATIENT SAMPLES ((B)(6)) THAT HAD CAUSED (B)(6) TEST RESULTS. AT THE TIME THE RETURNED MATERIAL ARRIVED ON OUR PREMISES, L THE SUPPOSEDLY DEFECTIVE PRODUCT WAS ALREADY EXPIRED. NEVERTHELESS BOTH PATIENT SAMPLES WERE TESTED WITH THE RETURNED PRODUCT SAMPLE ON TANGO OPTIMO. PATIENT SAMPLE #(B)(6) REACTED NEGATIVELY, WHILE PATIENT SAMPLE #(B)(4) SHOWED CORRECT POSITIVE RESULTS WITH THE RETURNED PRODUCT SAMPLE AS WELL AS WITH OUR QC LAB'S RETAINED SAMPLE AND THE CURRENT LOT OF BIOTESTCELL 1&2. SAMPLE #(B)(6) COULD NOT BE TESTED FURTHERMORE, BECAUSE IT WAS DEPLETED. AT FINAL SEROLOGICAL CONTROL TESTING BIOTESTCELL 1&2 WAS TESTED WITH DIFFERENT CONTROLS AND SAMPLES, E.G. ANTI-D AND ANTI-FY(A). ALL (B)(6) AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTION. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THAT THE ALLEGEDLY DEFECTIVE LOT OF BIOTESTCELL 1&2 FUNCTIONS CORRECTLY. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. THE AFFECTED TANGO OPTIMO WAS INSPECTED BY OUR FIELD SERVICE ENGINEERS AND NO INDICATION FOR AN INSTRUMENT OR SOFTWARE MALFUNCTION COULD BE IDENTIFIED ON CURRENT DATA. THE INSTRUMENT WAS CONFIRMED TO OPERATE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AN ANTI-FY(A) WAS MISSED WITH BIOTESTCELL 1&2 WHEN TESTING ON TANGO OPTIMO. CUSTOMER REPORTED THAT THE PATIENT SAMPLE SHOWED A POSITIVE RESULT IN THE FIRST RUN ON TANGO OPTIMO. BUT WHEN THE SCREENING TEST WAS REPEATED ON TANGO OPTIMO, IT WAS NEGATIVE. OUR QUALITY CONTROL IS STILL WAITING FOR THE SUPPOSEDLY DEFECTIVE PRODUCT AND THE PATIENT SAMPLES THAT HAD CAUSED FALSE NEGATIVES. INFORMATION ON THE AFFECTED TANGO OPTIMO WAS REQUESTED AND WE ARE AWAITING THE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847457 REAGENT RED BLOOD CELLS BIOTESTCELL 1&2 BIOTESTCELL 1&2 KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH 8643011-00 07611969952380

    Patients

    Seq Age Sex Outcome Treatment
    1 ANTI-IGG, LOT 8608120-04, EXP. 08/19/2017| BIOTESTCELL I8, LOT 8641011-00, EXP. 12/05/2016| TANGO OPTIMO, # 9142400425