BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAGENT RED BLOOD CELLS IH-CELL A1 & B

    MDR report key: 8251812 · Received January 16, 2019

    Report

    Report Number
    9610824-2018-00092
    Event Type
    Malfunction
    Date Received
    January 16, 2019
    Report Date
    January 11, 2021
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    QHT
    UDI-DI
    07611969952243
    PMA / PMN Number
    125208
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, 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 FALSE NEGATIVE REACTIONS OF SEVERAL SPECIMENS WITH IH-CELL A1&B. THE ISSUE HAPPENED ON TWO IH-1000 ANALYZERS. NO SPECIFIC DATE WAS MENTIONED REGARDING AN INCREASE IN ABO DISCREPANCIES TO ANALYZE. THE CUSTOMER STATED THAT THE REACTIONS OF BLOOD GROUP A SAMPLES WERE FALSE NEGATIVE WITH IH-CELL B. HE ALSO STATED THAT THE REVERSE TYPE DID NOT MATCH THE FRONT TYPE. DUE TO THE DISCREPANCY BETWEEN FORWARD AND REVERSE TYPING THE IH-1000 STATED "ABO NOT INTERPRETABLE" AND NO INCORRECT RESULTS WERE RELEASED. THE COMPLAINT WAS INITIALLY RAISED WHEN IH-CELL A1,B LOT 8843011 (EXPIRY DATE DECEMBER 17, 2018) WAS IN USE. THIS LOT HAD ALREADY BEEN EXPIRED AT THE DATE OF THE RECEIPT OF THE COMPLAINT. HOWEVER, THE CUSTOMER DID NOT COMPLAIN ABOUT ONE PARTICULAR LOT OF IH-CELL A&B, BUT RATHER THE GEL TECHNIQUE ITSELF IN CONNECTION WITH THE REVERSE TYPING. THE CUSTOMER PROVIDED US PLASMA OF TWELVE (12) BLOOD GROUP A DONOR SAMPLES INCLUDING THEIR CORRESPONDING RESULT IMAGES AND TESTING RECORDS WHICH GAVE NEGATIVE RESULTS WITH IH-CELL B ON IH-1000. THE SAMPLES WERE UP TO THREE MONTHS OLD AT THE TIME OF TESTING - HAD BEEN STORED FROZEN AT THE CUSTOMER LABORATORY PRIOR TO TRANSPORT AT 2-8°C. AT THE CUSTOMER'S SITE THE SAMPLES WERE ALSO TESTED ON A COMPETITOR ANALYZER WHERE THE RESULT WITH THE B CELL WERE ALSO NEGATIVE. HOWEVER, IN MANUAL TUBE USING BIOTESTCELL A1&B REACTIONS WITH THE B CELL WERE 2+ OR 3+ OR 4+ (DEPENDING ON THE DONOR SAMPLE TESTED). IH-CARD CONFIGURATION USED BY CUSTOMER WAS IH-CARD ABO/D(DVI+)+REV A1,B WHEREBY MANY LOT NUMBERS HAVE BEEN USED INCLUDING LOT 8748090. THE TWELVE (12) SAMPLES SENT FROM THE CUSTOMER WERE TESTED IN THE CUSTOMERS LABORATORY USING IH-CELL A1,B LOT 8847011 AND IH-CELL A1,B LOT 8850011. OUR COMPLAINT LABORATORY TESTED THE TWELVE AFFECTED DONOR SAMPLES INITIALLY ON IH-1000 WITH IH-CARD ABO/D(DVI+)+REV A1,B LOT 8748090 AND IH-CELL A1 & B LOT 8903011. EIGHT (8) OF THE TWELVE (12) DONOR SAMPLES GAVE NEGATIVE REACTION IN IH-CELL B. FOUR (4) OF THE 12 DONOR SAMPLES GAVE A 1+ REACTION IN IH-CELL B. SUBSEQUENTLY THE REVERSE TYPING OF THE 12 DONOR SAMPLES WAS PERFORMED IN TUBE TEST. EIGHT (8) OF THE TWELVE (12) SAMPLES GAVE NEGATIVE RESULTS IN TUBE TESTING WITH REVERSE CELL B. THREE (3) SAMPLES GAVE A 1+ REACTION AND ONE (1) SAMPLE GAVE A 2+ REACTION. THE STRONG 3+ OR 4+ REACTION IN TUBE THAT THE CUSTOMER REPORTED FOR THOSE SAMPLES COULD NOT BE REPRODUCED. IN SUMMARY THE REVERSE GROUP RESULTS WERE NOT IN CONCORDANCE WITH THE FORWARD GROUP IN EIGHT (8) OF THE TWELVE (12) DONOR SAMPLES PROVIDED BY THE CUSTOMER. HOWEVER, IT HAS TO BE NOTED THAT THE CUSTOMER HAS A VERY HIGH NUMBER OF SAMPLES TESTED PER DAY. THERE ARE APPROXIMATELY 2-5 SAMPLES PER DAY WHICH SHOW A FALSE NEGATIVE REACTION IN IH-CELL B, OUT OF 1400+ SAMPLES. THIS IS NOT A STATISTICAL SIGNIFICANCE (<0.5%). IT IS ALSO NOTED THAT THE COMPETITOR ANALYZER IS CONSISTENT WITH IH-1000 RESULTS REGARDING NON-REACTIVE B CELLS. IT IS NOT UNEXPECTED TO SEE AS MANY AS 2.5% OF HEALTHY DONORS PRESENT WITH NEGATIVE REACTIONS IN GEL CARD IN CASE OF A LOW ISOAGGLUTININ TITER. IT SHOULD ALSO BE NOTED THAT ABO ISOAGGLUTININS DECLINE WITH AGE - THE CUSTOMER DID NOT PROVIDED THE AGE OF THE DONORS PRESENTED IN THIS COMPLAINT. THERE IS NO UPPER AGE LIMIT FOR DONATION IN THE UNITED STATES OF AMERICA. FURTHERMORE, THE ISOAGGLUTININ TITER HAVE A HIGH VARIANCE AND CAN ALSO DROP IN CASE OF CONSUMPTION OF HIGHLY PROCESSED FOOD (REFERRING TO TECHNICAL MANUAL AABB 19TH EDITION). THE PRODUCTS ITSELF ARE DEEMED AS SUITABLE FOR APPLICATION AS THE CAUSE OF THE COMPLAINT IS NEITHER A DEFECT WITH THE IH-CARD NOR THE IH-CELLS BUT RATHER IS RELATED TO THE DONOR / DONOR SAMPLE TESTED. THE SECTION LIMITATION OF THE INSTRUCTION FOR USE CONTAINS AN APPROPRIATE NOTE: "DECREASED OR MISSING ABO ANTIBODY REACTIVITY MAY BE SEEN IN DISEASE STATES, THE ELDERLY OR INFANTS RESULTING IN FALSE NEGATIVE REACTIONS." A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. AS THE INSTRUCTION FOR USE ALREADY CONTAINS AN APPROPRIATE NOTE, NO FURTHER INVESTIGATIONS OR ACTIONS HAVE TO BE INITIATED.

    Additional Manufacturer Narrative · 1

    THIS IS OUR INITIAL REPORT ON THIS INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSE NEGATIVE REACTIONS OF THREE SPECIMENS WHEN TESTED USING IH-CELL A1&B ON IH-1000. THE CUSTOMER STATED THAT THE REACTIONS OF BLOOD GROUP A SAMPLES WERE FALSE NEGATIVE WITH IH-CELL B. HE ALSO STATED THAT THE REVERSE TYPE DID NOT MATCH THE FRONT TYPE. DUE TO THE DISCREPANCY BETWEEN FORWARD AND REVERSE TYPING THE IH-1000 STATED "ABO NOT INTERPRETABLE" AND NO INCORRECT RESULTS WERE RELEASED. THE CUSTOMER HAS NOT REPORTED THE DATE OF EVENT AND ALSO DID NOT RETURN THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING. HE ANNOUNCED THAT HE WILL RETURN THE SAMPLES THAT HAD CAUSED FALSE NEGATIVE TEST RESULTS FOR INVESTIGATION. WE ARE STILL WAITING FOR THE LOT INFORMATION AND THE DONOR SAMPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45351 REAGENT RED BLOOD CELLS IH-CELL A1 & B IH-CELL A1 & B; 2X10 ML QHT BIO-RAD MEDICAL DIAGNOSTICS GMBH 8843011 07611969952243

    Patients

    Seq Age Sex Outcome Treatment
    1 IH-1000, # 5100028| IH-1000, # 5100028| IH-1000, # 5100035| IH-1000, # 5100035| IH-CARD ABO/D(DVI+)+REV A1,B, LOT 8748090| IH-CELL A1&B, LOT 8847011| IH-CELL A1&B, LOT 8850011