BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION®

    MDR report key: 7427108 · Received April 12, 2018

    Report

    Report Number
    2517506-2018-00258
    Event Type
    Malfunction
    Date Received
    April 12, 2018
    Date of Event
    March 14, 2018
    Report Date
    June 13, 2018
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JFJ
    UDI-DI
    00842768005404
    PMA / PMN Number
    K942640
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ORIGINAL MDR(B)(6) 2018. (ADDITIONAL INFORMATION 21-MAY-2018) SIEMENS HEADQUARTERS SUPPORT CENTER (HSC) EVALUATED INSTRUMENT DATA LOGS AND THE AVAILABLE INFORMATION. THE CUSTOMER CONFIRMED THAT NO MEDICAL PROCEDURE WAS PERFORMED ON THE PATIENT NOR TREATMENT MODIFIED BASED UPON THE DISCORDANT ELEVATED AMYLASE (AMY) RESULT. INSTRUMENT DAILY SYSTEM CHECKS DISPLAYED NO ATYPICAL PERFORMANCE. AMY CALIBRATION DATA WAS WITHIN CONFORMANCE AT THE TIME OF THE EVENT. QUALITY CONTROL RESULTS WERE REPORTED AS RECOVERING WITHIN THE CUSTOMER ESTABLISHED RANGES. A CUSTOMER SERVICE ENGINEER WAS DISPATCHED TO THE SITE AND DID NOT IDENTIFY ANY INSTRUMENT MALFUNCTIONS. HSC CONCLUDED THAT NO PRODUCT NON-CONFORMANCE WAS IDENTIFIED. THE CAUSE IS UNKNOWN. THE DEVICE IS OPERATING WITHIN SPECIFICATIONS. NO FURTHER INVESTIGATION IS REQUIRED. SECTION H6 HAS BEEN UPDATED TO REFLECT THE HSC CONCLUSION.

    Additional Manufacturer Narrative · 1

    MDR 2517506-2018-00260 WAS ALSO FILED FOR THE SAME AMY EVENT. THE CUSTOMER CONTACTED SIEMENS CUSTOMER CARE CENTER (CCC) AND REPORTED THAT A DISCORDANT, FALSELY ELEVATED AMYLASE (AMY) PATIENT RESULT WAS OBTAINED ON THE DIMENSION RXL MAX HM SYSTEM. SIEMENS IS INVESTIGATING THE INCIDENT.

    Description of Event or Problem · 1

    A DISCORDANT, FALSELY ELEVATED AMYLASE (AMY) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION RXL MAX HM SYSTEM. THE RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THE SAME SAMPLE WAS TESTED ON THE SAME INSTRUMENT AT A LATER DATE AND AN ELEVATED RESULT WAS OBTAINED. THE PATIENT WAS HOSPITALIZED FOR SUSPECTED PANCREATITIS. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ELEVATED AMY RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267408 DIMENSION® DIMENSION® AMY AMYLASE FLEX® REAGENT CARTRIDGE JFJ SIEMENS HEALTHCARE DIAGNOSTICS INC. EA8299 00842768005404

    Patients

    Seq Age Sex Outcome Treatment
    1