BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANGO OPTIMO

    MDR report key: 3911483 · Received July 3, 2014

    Report

    Report Number
    9610824-2014-00049
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    May 31, 2014
    Report Date
    July 9, 2014
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    PMA / PMN Number
    BK080013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS OUR INITIAL REPORT ON THIS INCIDENT.

    Additional Manufacturer Narrative · 1

    THE STATED DATE OF EVENT IN OUR FOLLOW-UP REPORT #01 WAS INCORRECT. IT SHOULD HAVE BEEN (B)(6) 2014 INSTEAD OF (B)(6) 2014.

    Additional Manufacturer Narrative · 1

    THIS IS OUR FINAL REPORT ON THIS INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HE MISSED AN ANTI-E AND ANTI-S WHEN TESTING WITH BIOTESTCELL 3 ON TANGO OPTIMO. THE CUSTOMER REPORTED THAT THE IMAGES APPEARED VISUALLY POSITIVE AND THEREFORE THE NEGATIVE RESULTS OF TANGO OPTIMO WERE EDITED BY TECHNICIAN. THE CUSTOMER HAS NEITHER RETURNED THE SAMPLES THAT HAD CAUSED A FALSE NEGATIVE TEST RESULT NOR THE SUPPOSEDLY DEFECTIVE PRODUCT NOR THE IMAGES OF TANGO OPTIMO. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THE RETAINED TANGO OPTIMO SAMPLE WITH NEGATIVE AND POSITIVE CONTROL AND SOME ANTIBODIES, E.G. ANTI-E. ALL POSITIVE 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 3 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. ITS CAMERA VALUES WERE FOUND TO BE OUT OF RANGE AND HAVE BEEN ADJUSTED TO THE VALID RANGE. AFTER THIS SERVICE INTERVENTION, THE CUSTOMER FEELS COMFORTABLE WITH THE INSTRUMENT PERFORMANCE NO FURTHER ISSUES WERE REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HE MISSED AN ANTI-E AND ANTI-S WHEN TESTING WITH BIOTEST CELL 3 ON TANGO OPTIMO. THE CUSTOMER REPORTED THAT THE IMAGES APPEARED VISUALLY POSITIVE AND THEREFORE THE NEGATIVE RESULTS OF TANGO OPTIMO WERE EDITED BY TECHNICIAN. THE CUSTOMER HAS NEITHER RETURNED THE SAMPLES THAT HAD CAUSED A FALSE NEGATIVE TEST RESULT NOR THE SUPPOSEDLY DEFECTIVE PRODUCT NOR THE IMAGES OF TANGO OPTIMO. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THE RETAINED TANGO OPTIMO SAMPLE WITH NEGATIVE AND POSITIVE CONTROL AND SOME ANTIBODIES, E.G. ANTI-E. ALL POSITIVE 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 3 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. ITS CAMERA VALUES WERE FOUND TO BE OUT OF RANGE AND HAVE BEEN ADJUSTED TO THE VALID RANGE. AFTER THIS SERVICE INTERVENTION, THE CUSTOMER FEELS COMFORTABLE WITH THE INSTRUMENT PERFORMANCE NO FURTHER ISSUES WERE REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HE MISSED AN ANTI-E AND ANTI-S WHEN TESTING WITH BIOTESTCELL 3 ON TANGO OPTIMO. THE CUSTOMER REPORTED THAT THE IMAGES APPEARED VISUALLY POSITIVE AND THEREFORE THE NEGATIVE RESULTS OF TANGO OPTIMO WERE EDITED BY TECHNICIAN. THE CUSTOMER HAS NEITHER RETURNED THE SAMPLES THAT HAD CAUSED A FALSE NEGATIVE TEST RESULT NOR THE SUPPOSEDLY DEFECTIVE PRODUCT NOR THE IMAGES OF TANGO OPTIMO. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THE RETAINED TANGO OPTIMO SAMPLE WITH NEGATIVE AND POSITIVE CONTROL AND SOME ANTIBODIES, E.G. ANTI-E. ALL POSITIVE 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 3 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. ITS CAMERA VALUES WERE FOUND TO BE OUT OF RANGE AND HAVE BEEN ADJUSTED TO THE VALID RANGE. WE ARE WAITING FOR A FOLLOW-UP REPORT ON THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389174 TANGO OPTIMO AUTOMATED BLOOD BANK ANALYSER SYSTEM KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH 8416021-00

    Patients

    Seq Age Sex Outcome Treatment
    1 AHG, LOT 8343150-03| MLB2, LOT 8344050-00| MLB2, LOT 8344050-00| AHG, LOT 8343150-03| BIOTESTCELL 3, LOT 8416021-00, EXP. 06/09/2014| MLB2, LOT 8344050-00| TANGO OPTIMO, # (B)(4)| AHG, LOT 8343150-03| BIOTESTCELL 3, LOT 8416021-00, EXP. 06/09/2014