BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE SOB PANEL

    MDR report key: 17607179 · Received August 23, 2023

    Report

    Report Number
    3013982035-2023-00022
    Event Type
    Malfunction
    Date Received
    August 23, 2023
    Date of Event
    June 13, 2023
    Report Date
    August 23, 2023
    Manufacturer
    QUIDEL CARDIOVASCULAR INC.
    Product Code
    MMI
    PMA / PMN Number
    K080269
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION CONCLUSION: THE CUSTOMER'S COMPLAINT WAS NOT REPLICATED WITH IN-HOUSE TESTING OF RETAINED DEVICES OF LOT NUMBER T13650N. RETAINS OF THE COMPLAINT LOT WERE TESTED WITH A POSITIVE CALIBRATOR, NO ISSUES WITH TNI RECOVERY WERE OBSERVED. THE LOT PERFORMED WITHIN SPECIFICATION. MANUFACTURING BATCH RECORDS FOR LOT T13650N WERE REVIEWED AND FOUND THAT THE LOT MET FINAL RELEASE SPECIFICATIONS. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY AND NO CORRECTIVE ACTION IS REQUIRED.

    Description of Event or Problem · 0

    EVENT OCCURRED IN INDIA. CONFLICTING RESULTS ON 1 PATIENT. PATIENT SYMPTOMS: MILD CHEST PAIN. DIAGNOSIS: MILD MI W/ DELAY IN TREATMENT. CARDIO 3 TNI= 0.04 NG/ML; CUTOFF: >0.02 NG/ML.. SOB TNI= <0.05 NG/ML; CUTOFF: >0.40 NG/ML.. COMPARATIVE VITROSTNI= 0.0445 NG/ML; CUTOFF: 9 PG/L (F), 12 PG/L (M).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1496384 TRIAGE SOB PANEL TRIAGE SOB PANEL MMI QUIDEL CARDIOVASCULAR INC. 97300EU T13650N

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown TRIAGE METERPRO PN: 55070, SN:(B)(6).