BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALINITY I TOTAL B-HCG REAGENT KIT

    MDR report key: 22688413 · Received August 1, 2025

    Report

    Report Number
    3005094123-2025-00379
    Event Type
    Injury
    Date Received
    August 1, 2025
    Date of Event
    May 30, 2025
    Report Date
    August 25, 2025
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    DHA
    UDI-DI
    00380740163327
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. A SEARCH FOR SIMILAR COMPLAINTS DID IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY FOR LOT 70286UD02, HOWEVER, AN INCREASE IN COMPLAINT ACTIVITY WAS NOT IDENTIFIED REGARDING COMMONALITIES FOR COMPLAINT LOT NUMBER AND ISSUE. ACCURACY TESTING WAS COMPLETED WITH A RETAINED KIT OF THE COMPLAINT LOT. ALL VALIDITY AND ACCEPTANCE CRITERIA WERE MET DURING COMPLETION OF THE PROTOCOL, DEMONSTRATING THAT THE LOT IS PERFORMING AS EXPECTED. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH LOT 70286UD02 AND COMPLAINT ISSUE. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER¿S ISSUE. PER THE LIMITATIONS OF THE PROCEDURE SECTION OF THE PACKAGE INSERT, INTERFERING SUBSTANCES (SUCH AS HETEROPHILIC ANTIBODIES, NONSPECIFIC PROTEINS, OR HCG-LIKE SUBSTANCES) MAY FALSELY DEPRESS OR FALSELY ELEVATE RESULTS. THESE INTERFERING SUBSTANCES MAY CAUSE FALSE RESULTS OVER THE ENTIRE RANGE OF THE ASSAY, NOT JUST AT LOW LEVELS, AND MAY INDICATE THE PRESENCE OF HCG WHEN THERE IS NONE. HETEROPHILIC ANTIBODIES IN HUMAN SERUM CAN REACT WITH REAGENT IMMUNOGLOBIN, INTERFERING WITH IN VITRO IMMUNOASSAYS. PATIENTS ROUTINELY EXPOSED TO ANIMALS OR TO SERUM PRODUCTS CAN BE PRONE TO THIS INTERFERENCE AND ANOMALOUS VALUES MAY BE OBSERVED. ADDITIONALLY, SPECIMENS FROM PATIENTS WHO HAVE RECEIVED PREPARATIONS OF MOUSE MONOCLONAL ANTIBODIES FOR DIAGNOSIS OR THERAPY MAY CONTAIN HUMAN ANTI-MOUSE ANTIBODIES (HAMA). SUCH SPECIMENS MAY SHOW EITHER FALSELY ELEVATED OR DEPRESSED VALUES WHEN TESTED WITH ASSAY KITS SUCH AS ALINITY I TOTAL B-HCG THAT EMPLOY MOUSE MONOCLONAL ANTIBODIES. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I TOTAL B-HCG REAGENT LOT 70286UD02 WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I TOTAL B-HCG RESULTS FOR MULTIPLE SAMPLES ON A 21 YEAR FEMALE PATIENT WITH INFLAMMATORY SPONDYLOPATHY. THE FOLLOWING INFORMATION WAS PROVIDED: (B)(6) 2025: INITIAL RESULT = 7.89 MIU/ML (B)(6) 2025: INITIAL RESULT = 9.10 MIU/ML (B)(6) 2025: INITIAL RESULT = 10.06 MIU/ML (B)(6) 2025: INITIAL RESULT = 14.42 MIU/ML THE PHYSICIAN QUESTIONED THE ALINITY I B.-HCG RESULTS BECAUSE AFTER A MEDICAL ABORTION, THE PATIENT¿S ROCHE TEST RESULT AT ANOTHER HOSPITAL HAD BEEN NEGATIVE, THEN A POSITIVE RESULT APPEARED WHEN RETURNING FOR TREATMENT AT THIS HOSPITAL. THE CUSTOMER INDICATED THE PATIENT HAS UNDERGONE 2 UNNECESSARY MEDICAL ABORTIONS DUE TO THE FALSELY ELEVATED RESULTS. ADDITIONAL TESTING WAS COMPLETED ON THE SAMPLE AT THE CUSTOMER SITE: UNDILUTED RESULT = 17.03 MIU/ML HETEROPHILIC BLOCKING TUBE (HBT) WAS <1.2 MIU/ML. THE (B)(6) 2025 SAMPLE WAS SENT TO OTHER HOSPITALS FOR TESTING ON OTHER PLATFORMS FOR TROUBLESHOOTING PURPOSES ONLY: ARCHITECT I2000SR = 15.02 MIU/ML, REPEAT WITH HETEROPHILIC BLOCKING TUBE (HBT) = 0.99 MIU/ML MINDRAY CI6000L WAS <0.5, REPEAT WITH HETEROPHILIC BLOCKING TUBE (HBT) WAS <0.5 SIEMENS CENTAUR AP WAS <2.0 REPEAT WITH HETEROPHILIC BLOCKING TUBE (HBT) = WAS <2.0 THE CUSTOMER INDICATED A DAVID COLLOIDAL GOLD RESULT WAS CONSISTENT WITH THE ABBOTT RESULTS. ADDITIONAL LABORATORY DATA WAS PROVIDED: LH = 4.43, REPEAT WITH HETEROPHILIC BLOCKING TUBE (HBT) = 4.91 FREE T3 = 4.66 FREE T4 = 19.33. NO ADDITIONAL IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I TOTAL B-HCG RESULTS FOR MULTIPLE SAMPLES ON A 21 YEAR FEMALE PATIENT WITH INFLAMMATORY SPONDYLOPATHY. THE FOLLOWING INFORMATION WAS PROVIDED: (B)(6) 2025: INITIAL RESULT = 7.89 MIU/ML. (B)(6) 2025: INITIAL RESULT = 9.10 MIU/ML. (B)(6) 2025: INITIAL RESULT = 10.06 MIU/ML. (B)(6) 2025: INITIAL RESULT = 14.42 MIU/ML. THE PHYSICIAN QUESTIONED THE ALINITY I B-HCG RESULTS BECAUSE AFTER A MEDICAL ABORTION, THE PATIENT¿S ROCHE TEST RESULT AT ANOTHER HOSPITAL HAD BEEN NEGATIVE, THEN A POSITIVE RESULT APPEARED WHEN RETURNING FOR TREATMENT AT THIS HOSPITAL. THE CUSTOMER INDICATED THE PATIENT HAS UNDERGONE 2 UNNECESSARY MEDICAL ABORTIONS DUE TO THE FALSELY ELEVATED RESULTS. ADDITIONAL TESTING WAS COMPLETED ON THE SAMPLE AT THE CUSTOMER SITE: UNDILUTED RESULT = 17.03 MIU/ML. HETEROPHILIC BLOCKING TUBE (HBT) WAS <1.2 MIU/ML. THE (B)(6) 2025 SAMPLE WAS SENT TO OTHER HOSPITALS FOR TESTING ON OTHER PLATFORMS FOR TROUBLESHOOTING PURPOSES ONLY: ARCHITECT I2000SR = 15.02 MIU/ML, REPEAT WITH HETEROPHILIC BLOCKING TUBE (HBT) = 0.99 MIU/ML MINDRAY CI6000L WAS <0.5, REPEAT WITH HETEROPHILIC BLOCKING TUBE (HBT) WAS <0.5 SIEMENS CENTAUR AP WAS <2.0 REPEAT WITH HETEROPHILIC BLOCKING TUBE (HBT) = WAS <2.0 THE CUSTOMER INDICATED A DAVID COLLOIDAL GOLD RESULT WAS CONSISTENT WITH THE ABBOTT RESULTS. ADDITIONAL LABORATORY DATA WAS PROVIDED: LH = 4.43, REPEAT WITH HETEROPHILIC BLOCKING TUBE (HBT) = 4.91. FREE T3 = 4.66. FREE T4 = 19.33 . NO ADDITIONAL IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325939 ALINITY I TOTAL B-HCG REAGENT KIT SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN DHA ABBOTT IRELAND DIAGNOSTICS DIVISION 70286UD02 00380740163327

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Female Disability ALNTY I PROCESSING MODU, 03R65-01, (B)(6).| ALNTY I PROCESSING MODU, 03R65-01, (B)(6).