BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS BETA-CROSSLAPS/SERUM

    MDR report key: 19312618 · Received May 14, 2024

    Report

    Report Number
    1823260-2024-01443
    Event Type
    Malfunction
    Date Received
    May 14, 2024
    Date of Event
    April 21, 2024
    Report Date
    June 14, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JMM
    UDI-DI
    04015630940141
    PMA / PMN Number
    K993706
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SERIAL NUMBER OF THE CUSTOMER'S COBAS 8000 CORE UNIT IS 2137-04. THE PATIENT SAMPLE WAS REQUESTED FOR INVESTIGATION. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE PATIENT SAMPLE WAS NOT RECEIVED FOR INVESTIGATION. THE INVESTIGATION REVIEWED THE CALIBRATION DATA. THE CALIBRATOR 1 SIGNAL IS WITHIN RANGE AND THE CALIBRATOR 2 SIGNAL IS SLIGHTLY BELOW THE LOWER RANGE. THE INVESTIGATION REVIEWED THE QC DATA AND THE RESULTS WERE WITHIN SPECIFICATIONS BEFORE THE PATIENT SAMPLE WAS RUN. THE INVESTIGATION REVIEWED THE ALARM TRACE AND NO ISSUES WERE NOTED. THE INVESTIGATION REVIEWED THE CUSTOMER'S HANDLING OF PATIENT SAMPLES. THE PATIENT SAMPLE TUBE WAS CENTRIFUGED IN A FIXED-TYPE CENTRIFUGE UNIT. THE INVESTIGATION DETERMINED THAT SWING-OUT ROTORS BE USED FOR THE CENTRIFUGATION OF THE SAMPLE TUBE. THE INVESTIGATION REVIEWED THE IMAGES FROM THE SAMPLE-FOAM DETECTION CAMERA AND NO ISSUES WERE NOTED. BASED ON THE INFORMATION PROVIDED, THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS B-CROSSLAPS/SERUM (B-CROSSLAPS) RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS 8000 CORE UNIT. ON (B)(6) 2024, THE INITIAL RESULT FROM THE ANALYZER WAS <10 PG/ML. THE FIRST REPEAT RESULT WAS CONSISTENT. THE REPORTER NOTED THAT THE PATIENT HAS OSTEOPOROSIS AND SECONDARY HYPERPARATHYROIDISM AND THAT HER OTHER BONE MARKERS (N-MID AND TP1NP) WERE BOTH WITHIN THE REFERENCE RANGE. THE REPORTER QUESTIONED THE INITIAL RESULT AND SENT THE PATIENT SAMPLE FOR FURTHER TESTING USING A DOMESTIC PLATFORM WITH CHEMILUMINESCENCE IMMUNOASSAY (CLIA) AS THE LABORATORY METHOD. ON (B)(6) 2024, THE SECOND REPEAT RESULT FROM THE DOMESTIC PLATFORM USING THE CLIA METHOD WAS 34 PG/ML (REFERENCE RANGE <1017 PG/ML).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648413 ELECSYS BETA-CROSSLAPS/SERUM HYDROXYPROLINE TEST SYSTEM JMM ROCHE DIAGNOSTICS 745601 04015630940141

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female ANTI-OSTEOPOROSIS DRUGS