BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD GROUPING REAGENT IH-CARD ABO/D(DVI-)+REV A1,B

    MDR report key: 10091535 · Received May 27, 2020

    Report

    Report Number
    9610824-2020-00029
    Event Type
    Malfunction
    Date Received
    May 27, 2020
    Date of Event
    April 30, 2020
    Report Date
    November 11, 2020
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    QHR
    UDI-DI
    07611969964529
    PMA / PMN Number
    125534
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS OUR FINAL REPORT ON THIS INCIDENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE INTERMITTENTLY OCCURRENCE OF FALSE POSITIVE RESULTS WHEN TESTING MANUALLY ON IH-READER 24. THE CUSTOMER INITIALLY CLAIMED THAT IH-CARD ABO/D(DVI-)+REV A1, B, LOT 8940010 WAS USED WHEN THE FALSE POSITIVE RESULT OCCURRED, THIS WAS LATER CORRECTED TO LOT 8939050. DURING OUR INVESTIGATION IT ALSO BECAME APPARENT THAT ON MAY 07, 2020 A FALSE POSITIVE RESULT ALSO OCCURRED WITH A SECOND IH-CARD LOT: LOT 8949160. THE CUSTOMER REPORTED THAT USED IH-CARD ABO/D(DVI-)+REV A1, B, ART, LOT 8939050 SHOWED FALSE POSITIVE REACTIONS WITH ANTI-B AND THE CONTROL WELL, IH-CARD ABO/D(DVI-)+REV.A1, B, LOT 8949160 SHOWED FALSE POSITIVE REACTIONS IN THE CONTROL WELL. IN REPETITION ALL RESULTS WERE AS EXPECTED. THE CUSTOMER STATED THAT THE GEL CARDS ARE STORED IN A COOL AREA IN THE BASEMENT. THE CUSTOMER DID NEITHER RETURN THE SUPPOSEDLY DEFECTIVE PRODUCTS FOR INVESTIGATIONAL TESTING NOR THE SAMPLES THAT HAD CAUSED FALSE POSITIVE TEST RESULTS. HOWEVER, THE CUSTOMER SUBMITTED IMAGES OF SOME TEST RESULT PRINTOUTS WHICH CONFIRMED THE DESCRIBED ISSUES OF FALSE POSITIVE REACTIONS. OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLES OF BOTH AFFECTED IH-CARD CONFIGURATIONS WITH DIFFERENT DONOR SAMPLES ON IH-READER 24 ALONG WITH THE REAGENT USED BY THE CUSTOMER, TO CONFIRM THAT THE REAGENT ITSELF DID NOT CONTRIBUTE TO THE INCORRECT RESULTS. ALL POSITIVE AND NEGATIVE RESULTS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POSITIVE REACTIONS. BECAUSE THE ROOT-CAUSE ANALYSIS OF THE FALSE POSITIVES WITHIN THE BLOOD GROUP TYPING IS EXTENSIVE THE ISSUE HAS BEEN ADDRESSED WITHIN A CORRECTIVE AND PREVENTIVE ACTION. THE INVESTIGATIONS ARE STILL ONGOING. IN ADDITION, THE RETENTION SAMPLES WERE VISUALLY CHECKED FOR INTACT SEALING, VISIBLE SUPERNATANT, HOMOGENEOUS GEL, THE GEL HEIGHT AND THE ABSENCE OF SPLASHES IN THE REACTION CHAMBER. THE GEL HEIGHT WAS MEASURED WITH A GAUGE. ALL ACCEPTANCE CRITERIA WERE MET. WE DID NEITHER OBSERVE VARYING LEVELS OF LIQUID NOR DEHYDRATION. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOTS. WE DID NOT RECEIVE ANY FURTHER COMPLAINT RELATED TO THIS LOT AND ISSUE. BASED ON THIS AND THE OUTCOME OF THE INVESTIGATION OF THE RETENTION SAMPLE A GENERAL ISSUE OF THIS PARTICULAR LOT COULD BE EXCLUDED. REGARDING THE DESCRIBED STORAGE CONDITIONS OF CUSTOMER, WE WOULD LIKE TO NOTE THAT THE REQUIRED STORAGE TEMPERATURE IS 18 TO 25 °C. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THAT THE ALLEGEDLY DEFECTIVE LOTS OF IH-CARD ABO/D(DVI-)+REV A1, B FUNCTION CORRECTLY AND DO NOT SHOW ANY SIGNS OF DEHYDRATION. FURTHER INVESTIGATIONS FOR SOLVING THE ISSUE ABOUT FALSE POSITIVE REACTIONS HAVE ALREADY BEEN INITIATED.

    Additional Manufacturer Narrative · 1

    THIS IS OUR INITIAL REPORT ON THIS INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSE POSITIVE RESULTS OF THE QC WITH ANTI-B AND THE CONTROL OF IH-CARD ABO/D(DVI-)+REV (B)(4), B ON THE IH-READER 24. THE CUSTOMER STATED THAT THEY REPEATED THE QC AND IT PASSED. THE CUSTOMER NOTICED VARYING GEL LEVELS ON SOME OF THE IH-CARDS. THE CUSTOMER DID NEITHER RETURN THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING NOR THE SAMPLES THAT HAD CAUSED FALSE POSITIVE TEST RESULTS. BUT HE PROVIDED IMAGES WHICH SHOWED THE FALSE POSITIVES. OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE WITH DIFFERENT CONTROLS AND DONOR SAMPLES ON THE IH-READER 24. ALL POSITIVE AND NEGATIVE RESULTS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POSITIVE REACTION. THE INVESTIGATION OF THE AFFECTED INSTRUMENT AT THE CUSTOMER´S SITE IS STILL ONGOING. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THAT THE ALLEGEDLY DEFECTIVE LOT OF IH-CARD ABO/D(DVI-)+REV (B)(4), B FUNCTIONS CORRECTLY. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554192 BLOOD GROUPING REAGENT IH-CARD ABO/D(DVI-)+REV A1,B IH-CARD ABO/D(DVI-)+REV A1,B; 288 CARDS QHR BIO-RAD MEDICAL DIAGNOSTICS GMBH 8939050 07611969964529

    Patients

    Seq Age Sex Outcome Treatment
    1 IH-CARD ABO/D(DVI-)+REV A1, B, LOT 8949160| IH-CARD GROUP ABO, LOT 8946080| IH-CARD GROUP ABO, LOT 8946080