BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY S CHAGAS

    MDR report key: 13056283 · Received December 21, 2021

    Report

    Report Number
    3002809144-2021-00711
    Event Type
    Malfunction
    Date Received
    December 21, 2021
    Date of Event
    November 7, 2021
    Report Date
    March 1, 2022
    Manufacturer
    ABBOTT GMBH
    Product Code
    QHM
    UDI-DI
    00380740117221
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS PERFORMED FOR FALSE REACTIVE RESULTS WHILE USING ALINITY S CHAGAS, LIST NUMBER (LN) 6P08-50, LOT 27175BE00. A REVIEW OF TICKETS WAS PERFORMED AND IDENTIFIED NORMAL COMPLAINT ACTIVITY. A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY ANY TRENDS FOR THE COMPLAINT ISSUE. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. REVIEW OF FIELD DATA WAS PERFORMED; THE ANALYSIS INCLUDED INITIAL REACTIVE RATES (IRR), REPEAT REACTIVE RATES (RRR) AND SPECIFICITY (ASSUMING ZERO PREVALENCE) AT OKLAHOMA BLOOD INSTITUTE (OBI), WHOLE BLOOD (WB) PEER SITES AND ACROSS ALL CUSTOMER SITES USING THIS LOT. THE SPECIFICITY AND REACTIVE RATE PERFORMANCE OF LOT 27175BE00 AT OBI IS WITHIN PRODUCT REQUIREMENTS AND COMPARABLE TO THE PERFORMANCE AT PEER SITES. FURTHER, AGGREGATED PERFORMANCE OF LOT 27175BE00 ACROSS ALL CUSTOMER SITES USING THIS LOT IS WITHIN PRODUCT REQUIREMENTS AND COMPARABLE TO THE PERFORMANCE OF OTHER LOTS OF THE SAME ASSAY. PERFORMANCE OF LOT 27175BE00: OBI: IRR: 0.072%; RRR: 0.072%; SPECIFICITY: 99.928% PEER SITES (EXCLUDING OBI): IRR: 0.084%; RRR: 0.084%; SPECIFICITY: 99.916% ALL CUSTOMER SITES: IRR: 0.090%; RRR: 0.090%; SPECIFICITY: 99.910% A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. A REVIEW OF LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY S CHAGAS, LIST NUMBER (LN) 6P08-50, LOT 27175BE00 WAS IDENTIFIED. SECTION G HAS BEEN UPDATED TO REFLECT PERSONNEL CHANGES THAT HAVE OCCURRED SUBSEQUENT TO THE INITIAL SUBMISSION.

    Additional Manufacturer Narrative · 0

    MULTIPLE PATIENTS WERE INVOLVED IN THIS EVENT. NO PATIENT DEMOGRAPHIC INFORMATION WAS PROVIDED. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 0

    THE CUSTOMER QUESTIONED REPEATEDLY REACTIVE ALINITY S CHAGAS RESULTS FOR FIVE PATIENTS. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2021 SID (B)(6) INITIAL RESULT (B)(6) S/CO (REACTIVE), REPEATED (B)(6) 2021 RESULT (B)(6) S/CO (REACTIVE) AND (B)(6) S/CO (REACTIVE; FINAL ASSAY INTERPRETATION REPEATEDLY REACTIVE) REPEAT CONFIRMATION RUNS USING ANOTHER METHOD (UNKNOWN) PENDING. (B)(6) 2021 SID (B)(6) INITIAL RESULT (B)(6) S/CO (REACTIVE), REPEATED (B)(6) 2021 RESULT (B)(6) S/CO (REACTIVE) AND (B)(6) S/CO (REACTIVE; FINAL ASSAY INTERPRETATION REPEATEDLY REACTIVE) REPEAT CONFIRMATION RUNS USING ANOTHER METHOD (UNKNOWN) NEGATIVE. (B)(6) 2021 SID (B)(6) INITIAL RESULT (B)(6) S/CO (REACTIVE), REPEATED (B)(6) 2021 RESULT (B)(6) S/CO (REACTIVE), REPEATED (B)(6) S/CO (REACTIVE; FINAL ASSAY INTERPRETATION REPEATEDLY REACTIVE) REPEAT CONFIRMATION RUNS USING ANOTHER METHOD (UNKNOWN) PENDING. (B)(6) 2021 SID (B)(6) INITIAL RESULT (B)(6) S/CO (REACTIVE), REPEATED (B)(6) 2021 RESULT (B)(6) S/CO (REACTIVE) AND (B)(6) S/CO (REACTIVE; FINAL ASSAY INTERPRETATION REPEATEDLY REACTIVE) REPEAT CONFIRMATION RUNS USING ANOTHER METHOD (UNKNOWN) POSITIVE. (B)(6) 2021 SID (B)(6) INITIAL RESULT (B)(6) S/CO (REACTIVE), REPEATED (B)(6) 2021 RESULT (B)(6) S/CO (REACTIVE) AND (B)(6) 2021 RESULT (B)(6) S/CO (REACTIVE; FINAL ASSAY INTERPRETATION REPEATEDLY REACTIVE) REPEAT CONFIRMATION RUNS USING ANOTHER METHOD (UNKNOWN) POSITIVE. IT IS UNKNOWN WHAT THE CUSTOMER BELIEVES THE CORRECT RESULT IS FOR EACH PATIENT. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1951938 ALINITY S CHAGAS TRYPANOSOMA CRUZI (E COLI, RECOMBINANT) ANTIGEN QHM ABBOTT GMBH 27175BE00 00380740117221

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ALNTY S SYSTEM, 06P16-01,(B)(6)