BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 11759489 · Received May 3, 2021

    Report

    Report Number
    9610824-2021-00028
    Event Type
    Malfunction
    Date Received
    May 3, 2021
    Date of Event
    April 5, 2021
    Report Date
    June 11, 2021
    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
    MA, 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 THAT FALSE POSITIVE REACTIONS OCCURED WITH THE ANTI-B OF IH-CARD ABO/D(DVI-)+REV.A1,B WHEN USED ON AN IH-1000 INSTRUMENT. THE CUSTOMER STATED THAT THE FALSE POSITIVE REACTIONS WERE 3 TO 4+ POSITIVE. FURTHERMORE, THE CUSTOMER STATED THAT THE ISSUE ONLY OCCURRED ON ONE ANALYZER. THE SECOND ANALYZER DID NOT HAVE THE ISSUE. THE CUSTOMER DID NOT PROVIDE A SAMPLE OF THE ALLEGEDLY DEFECTIVE PRODUCT NOR A PATIENT SAMPLE FOR INVESTIGATIONAL TESTING. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT WITH DIFFERENT DONOR SAMPLES ON IH-1000. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POSITIVE REACTION. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. THE CUSTOMER DID NOT PROVIDE TRACE FILES WERE FROM THE AFFECTED INSTRUMENT BUT HE PROVIDED SCREENSHOTS. BASED ON THE SCREENSHOTS THE COMPLAINT WAS CLASSIFIED AS CONFIRMED - UPP (UNEXPECTED PRODUCT PERFORMANCE). HOWEVER, SINCE THE PROBLEM ONLY OCCURRED ON ONE OF THE CUSTOMER'S DEVICES, A GENERAL LOT PROBLEM COULD BE RULED OUT. AN INTER-WELL CONTAMINATION IS SUSPECTED. BASED ON THE OBSERVED ISSUE AT THE CUSTOMER´S SITE WE ADVISED THE FOLLOWING POINTS: REPLACING THE NEEDLE IF IT WAS BENT OR DAMAGED, ADJUSTMENT OF THE NEEDLE CENTRING RELATIVELY TO THE IH CARD WELLS MUST BE PERFORMED FOR ALL POSITION IN THE PIPETTING AREA. CONTROL AND ADJUST THE DIAMETER OF THE HOLE PIERCED IH CARD. IT MUST BE CENTRED AND CHECKED BY THE DIAMETER TOOLS. ALSO ADVISED TO CHECK THE IH CARD PIN PIERCER, PLEASE REPLACE IT IF IT WAS DAMAGED OR PRESENTS SOME SMUDGE IN THE SURFACE.

    Additional Manufacturer Narrative · 1

    THIS IS OUR INITIAL REPORT ON THIS INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT FALSE POSITIVE REACTIONS OCCURED WITH THE ANTI-B OF IH-CARD ABO/D(DVI-)+REV.A1,B WHEN USED ON AN IH-1000 INSTRUMENT. THE CUSTOMER STATED THAT THE FALSE POSITIVE REACTIONS WERE 3 TO 4+ POSITIVE. FURTHERMORE, THE CUSTOMER STATED THAT THE ISSUE ONLY OCCURRED ON ONE ANALYZER. THE SECOND ANALYZER DID NOT HAVE THE ISSUE. THE CUSTOMER DID NOT PROVIDE A SAMPLE OF THE ALLEGEDLY DEFECTIVE PRODUCT NRO A PATIENT SAMPLE FOR INVESTIGATIONAL TESTING. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT WITH DIFFERENT DONOR SAMPLES ON IH-1000. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POSITIVE REACTION. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. AN INVESTIGATION REGARDING THE AFFECTED IH-1000 IS STILL ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660147 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 8048010 07611969964529

    Patients

    Seq Age Sex Outcome Treatment
    1 IH-1000, SN (B)(6)| IH-1000, SN (B)(6)| IH-1000, SN (B)(6)| IH-1000, SN (B)(6)