BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DG GEL 8 A/B/D (50 CARDS)

    MDR report key: 23165981 · Received September 29, 2025

    Report

    Report Number
    3002772505-2025-00006
    Event Type
    Malfunction
    Date Received
    September 29, 2025
    Date of Event
    August 30, 2025
    Report Date
    October 29, 2025
    Manufacturer
    DIAGNOSTIC GRIFOLS S.A.
    Product Code
    QHR
    UDI-DI
    08437014205930
    PMA / PMN Number
    BL 125452
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT INVOLVED RHD TYPING DISCREPANCIES IN TWO PATIENT SAMPLES TESTED USING GRIFOLS DG GEL CARDS. SAMPLE (B)(60 (FEMALE PATIENT) TESTED ON (B)(6) 2025 USING DG GEL 8 A/B/D (LOT 25007.01), DG GEL 8 NEUTRAL (LOT 25003.1.1), AND REVERSE-CYTE A1, B (LOT 641425033). RESULT: RH POSITIVE (3+) PATIENT HISTORY: A NEGATIVE, NO TRANSFUSIONS, PREGNANT, RECEIVED RHOGAM ON (B)(6) 2025. SAMPLE (B)(6) (MALE PATIENT) TESTED ON (B)(6) 2025 WITH THE SAME REAGENTS AND LOTS AS THE OTHER SAMPLE, DG GEL 8 A/B/D (LOT 25007.01), DG GEL 8 NEUTRAL (LOT 25003.01), AND REVERSE-CYTE A1, B (LOT 641425033). RESULT: RH POSITIVE (2+) PATIENT HISTORY: O NEGATIVE, RECEIVED TWO UNITS OF O NEGATIVE BLOOD IN (B)(6) 2024. ON (B)(6) 2025, BOTH SAMPLES WERE RETESTED USING DG GEL 8 A/B/D (LOT 25009.01.1), AGAIN SHOWING RHD POSITIVE (3+) RESULTS. TUBE TESTING WITH GRIFOLS ANTI-D REAGENT (LOT 029000) PRODUCED NEGATIVE RESULTS FOR BOTH SAMPLES. MANUAL GEL TESTING USING DG GEL 8 ABO/RH (2D) (LOT 25003.01.1) CONFIRMED RHD POSITIVE (3+) RESULTS IN BOTH D MICROTUBES. AN INTERNAL INVESTIGATION WAS CONDUCTED AT DIAGNOSTIC GRIFOLS FOLLOWING THE REPORT OF RHD TYPING DISCREPANCIES IN TWO PATIENT SAMPLES. AS PART OF THIS INVESTIGATION, THE DEVICE HISTORY RECORDS (DHR) FOR DG GEL 8 A/B/D CARD LOTS 25007.01.1 AND 25009.01.1 WERE REVIEWED. NO DEVIATIONS, ANOMALIES, OR INCIDENTS WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. QUALITY CONTROL DOCUMENTATION CONFIRMED THAT ALL RELEASE SPECIFICATIONS WERE MET, INCLUDING SPECIFICITY FOR RHD POSITIVE AND RHD NEGATIVE SAMPLES. TO FURTHER EVALUATE PRODUCT PERFORMANCE, TEN CONTROL SAMPLES WITH PREVIOUSLY CHARACTERIZED RHD PHENOTYPES, INCLUDING RHD POSITIVE, RHD NEGATIVE, WEAK D, AND DVI, WERE TESTED USING DG GEL 8 A/B/D CARDS (LOTS 25007.01.1 AND 25009.01.1) AND DG GEL 8 ABO/RH (2D) CARDS (LOT 25003.01.1). ALL RESULTS WERE CONSISTENT WITH EXPECTED REACTIVITY, CONFIRMING CORRECT PERFORMANCE OF THE CARDS AND EXCLUDING ANY MALFUNCTION OF THE PRODUCT. THE TWO PATIENT SAMPLES INVOLVED IN THE REPORTED EVENT WERE SUBSEQUENTLY TESTED USING DG GEL 8 ABO/RH (2D) CARDS (LOT 25001.01.1), YIELDING RHD POSITIVE RESULTS GRADED AT 3+ IN BOTH CASES. GENOTYPING OF BOTH SAMPLES WAS PERFORMED AT (B)(6), AND THE FOLLOWING RESULTS WERE OBTAINED: SAMPLE ID (B)(6): GENOTYPE RHDWEAK D TYPE 1 (RHD01W.1), RHDDELETION (RHD01N.01); PREDICTED PHENOTYPE: WEAK D. SAMPLE ID (B)(6): GENOTYPE RHDWEAK D TYPE 1 (RHD01W.1), RHDDELETION (RHD01N.01); PREDICTED PHENOTYPE: WEAK D. AS INDICATED IN THE RESULTS SECTION OF THE INSTRUCTIONS FOR USE OF THE DG GEL 8 ABO/RH (2D) CARDS, REACTION GRADES WEAKER THAN A STRONG POSITIVE MAY INDICATE A WEAK OR PARTIAL EXPRESSION OF ABO AND RHD ANTIGENS: "SAMPLES WITH NORMAL EXPRESSION OF ABO AND RHD ANTIGENS PROVIDE STRONG POSITIVE REACTION GRADES. WEAKER REACTIONS MAY INDICATE A WEAK OR PARTIAL EXPRESSION OF ABO AND RHD ANTIGENS." THE RESULTS OBTAINED ARE CONSISTENT WITH THE EXPECTED REACTIVITY OF WEAK D TYPE 1 SAMPLES AND SHOULD NOT BE CLASSIFIED AS FALSE POSITIVES. FURTHERMORE, IT IS IMPORTANT TO NOTE THAT WEAK D TYPE 1 INDIVIDUALS CAN BE SAFELY INTERPRETED AS RHD POSITIVE, WITH NO ASSOCIATED CLINICAL RISK. BASED ON THE GENOTYPING RESULTS AND THE PERFORMANCE OF THE GRIFOLS DG GEL CARD SYSTEM, NO MALFUNCTION HAS BEEN IDENTIFIED. THE OBSERVED RESULTS ARE ATTRIBUTABLE TO THE PRESENCE OF WEAK D VARIANTS, WHICH WERE CORRECTLY DETECTED BY THE SYSTEM.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL ONGOING, THE PATIENT'S SAMPLES HAVE BEEN SENT TO GRIFOLS LABORATORY SOLUTIONS IN SAN MARCOS FOR FURTHER TESTING. A FOLLOW-UP REPORT WILL BE SENT AFTER THE ANALYSIS OF RESULTS.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED RH DISCREPANCIES IN TWO DIFFERENT PATIENT SAMPLES: SAMPLE (B)(6) (FEMALE PATIENT) TESTED ON (B)(6) 2025 USING DG GEL 8 A/B/D (LOT 25007.01), DG GEL 8 NEUTRAL (LOT 25003.1.1), AND REVERSE-CYTE A1, B (LOT 641425033). RESULT: RH POSITIVE (3+) PATIENT HISTORY: A NEGATIVE, NO TRANSFUSIONS, PREGNANT, RECEIVED RHOGAM ON (B)(6) 2025. SAMPLE (B)(6) (MALE PATIENT) TESTED ON (B)(6) 2025 WITH THE SAME REAGENTS AND LOTS AS THE OTHER SAMPLE, DG GEL 8 A/B/D (LOT 25007.01), DG GEL 8 NEUTRAL (LOT 25003.01), AND REVERSE-CYTE A1, B (LOT 641425033). RESULT: RH POSITIVE (2+) PATIENT HISTORY: O NEGATIVE, RECEIVED TWO UNITS OF O NEGATIVE BLOOD IN (B)6) 2024. ON (B)(6) 2025, BOTH SAMPLES WERE RETESTED USING DG GEL 8 A/B/D (LOT 25009.01), AND BOTH SHOWED RH POSITIVE (3+) IN THE MICROTUBE D. ON (B)(6) 2025, THE SAMPLES WERE THEN TESTED USING THE DG GEL 8 ABO/RH (2D) CARD (LOT 25003.01), AND THE RESULTS OBTAINED FOR BOTH SAMPLES WERE ALSO POSITIVE (3+) IN THE TWO D WELLS. THIS CARD HAS THE SAME D CLONE AS THE DG GEL 8 A/B/D. FINALLY, BOTH SAMPLES WERE RETESTED USING TUBE TECHNIQUE WITH GRIFOLS ANTI-D REAGENT (LOT 029000), YIELDING NEGATIVE RESULTS (AS EXPECTED).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED RH DISCREPANCIES IN TWO DIFFERENT PATIENT SAMPLES: SAMPLE (B)(6) (FEMALE PATIENT) TESTED ON (B)(6) 2025 USING DG GEL 8 A/B/D (LOT 25007.01), DG GEL 8 NEUTRAL (LOT 25003.1.1), AND REVERSE-CYTE A1, B (LOT 641425033). RESULT: RH POSITIVE (3+) PATIENT HISTORY: A NEGATIVE, NO TRANSFUSIONS, PREGNANT, RECEIVED RHOGAM ON (B)(6) 2025. SAMPLE (B)(6) (MALE PATIENT) TESTED ON (B)(6) 2025 WITH THE SAME REAGENTS AND LOTS AS THE OTHER SAMPLE, DG GEL 8 A/B/D (LOT 25007.01), DG GEL 8 NEUTRAL (LOT 25003.01), AND REVERSE-CYTE A1, B (LOT 641425033). RESULT: RH POSITIVE (2+) PATIENT HISTORY: O NEGATIVE, RECEIVED TWO UNITS OF O NEGATIVE BLOOD IN (B)(6) 2024. ON (B)(6) 2025, BOTH SAMPLES WERE RETESTED USING DG GEL 8 A/B/D (LOT 25009.01), AND BOTH SHOWED RH POSITIVE (3+) IN THE MICROTUBE D. ON (B)(6) 2025, THE SAMPLES WERE THEN TESTED USING THE DG GEL 8 ABO/RH (2D) CARD (LOT 25003.01), AND THE RESULTS OBTAINED FOR BOTH SAMPLES WERE ALSO POSITIVE (3+) IN THE TWO D WELLS. THIS CARD HAS THE SAME D CLONE AS THE DG GEL 8 A/B/D. FINALLY, BOTH SAMPLES WERE RETESTED USING TUBE TECHNIQUE WITH GRIFOLS ANTI-D REAGENT (LOT 029000), YIELDING NEGATIVE RESULTS (AS EXPECTED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1217839 DG GEL 8 A/B/D (50 CARDS) BLOOD GROUPING REAGENT, PRODUCT CODE: QHR QHR DIAGNOSTIC GRIFOLS S.A. NA 25007.01 08437014205930

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other