BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIVERSATEK HEALTHCARE

    MDR report key: 25162623 · Received May 13, 2026

    Report

    Report Number
    2023374-2026-00002
    Event Type
    Malfunction
    Date Received
    May 13, 2026
    Date of Event
    April 9, 2026
    Report Date
    May 13, 2026
    Manufacturer
    DIVERSATEK HEALTHCARE
    Product Code
    FFT
    UDI-DI
    00816734022061
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE USER FACILITY REPORT STATED: 24 HR PH PROBE WOULD NOT CALIBRATE, CHECKED ALL CONNECTIONS, THEN RETRIED CALIBRATION, STILL WOULD NOT CALIBRATE, THEN CHANGED PH SOLUTIONS AGAIN AND THEN TRIED AGAIN, STILL WOULD NOT CALIBRATE. THERAPIES BEING USED ON THE PATIENT AT THE TIME OF THE EVENT THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT: NOT APPLICABLE. THE ABOVE FACILITY DID NOT REACH OUT TO DIVERSATEK HEALTHCARE PRIOR TO FILING A MEDWATCH REPORT WITH THE FDA. HOWEVER, IF THE REPORTER HAD REACHED OUT DIVERSATEK HEALTHCARE WOULD NOT HAVE REPROTED THIS INCIDENT TO THE FDA BECASUE THE MALFUNCTION REPORTED BY THE USER FACILITY DID NOT MEET THE CRITERIA FOR MANDATORY REPORTING. THIS REPORT IS IN RESPONSE TO THE USER FACILITY REPORT SENT TO THE FDA AND RECEIFED BY THE MANUFACTURER ON 29 APRIL 2026. THE FIRST STEP FOR USE OF THE ZEPHR REFLUX PROBES IS TO CONNECT THEM TO THE REUSABLE RECORDER AND PERFORM CALIBRATION. CALIBRATION OF THE PROBE IS PERFORMED OUTSIDE OF THE PATIENT AND WITHOUT PATIENT INVOLVEMENT. CALIBRATION OF THE PROBE COULD NOT BE COMPLETED. IF THE USER COULD NOT CALIBRATE THE DISPOSABLE PROBE, A PATIENT WAS NOT INVOLVED IN THIS EVENT. THEREFORE, IT IS UNKNOWN WHY THIS WAS REPORTED AS IT DOES NOT MEET THE THRESHOLD FOR A REPORTABLE EVENT. ADDITIONALLY, IF THE DISPOSABLE ZEPHR PROBE WERE TO FAIL DURING A REFLUX STUDY, IT WOULD POSE NO SAFETY RISK TO THE PATIENT. A REVIEW OF ALL COMPLAINT RECORDS SHOWED THIS LOT DID NOT HAVE ANY OTHER REPORTED ISSUES TO DIVERSATEK HEALTHCARE. BASED ON A REVIEW OF TRENDING REPORTS AND THE INFORMATION AVAILABLE, THE DEVICE DOES NOT POSE A SAFETY RISK EVEN IF CALIBRATION COULD NOT BE PERFORMED. ADDITIONALLY, PATIENT INVOLVEMENT BEGINS AFTER CALIBRATION IS COMPLETED, SO THE INABILITY TO INITIATE USE WOULD NEVER INVOLVE A PATIENT. DIVERSATEK HEALTHCARE HAS DETERMINED THAT THERE ARE NO NEW SAFETY OR EFFICACY ISSUES AS A RESULT OF THIS EVENT AND THEREFORE, NO FURTHER ACTION WILL BE TAKEN.

    Description of Event or Problem · 0

    PER MAUDE ADVERSE EVENT REPORT NUMBER(B)(4): IT WAS REPORTED THAT THE 24 HR PH PROBE WOULD NOT CALIBRATE, CHECKED ALL CONNECTIONS, THEN RETRIED CALIBRATION, STILL WOULD NOT CALIBRATE, THEN CHANGED PH SOLUTIONS AGAIN AND THEN TRIED AGAIN, STILL WOULD NOT CALIBRATE. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AND IT WAS CONFIRMED BY FURTHER FOLLOW UP TO THE REPORTER THAT THERE WAS NO PATIENT HARM. DIVERSATEK HEALTHCARE ACKNOWLEDGES RECEIPT OF THE FDA MEDWATCH REPORT REFERENCED ABOVE. UPON RECEIPT, THE REPORT WAS EVALUATED IN ACCORDANCE WITH OUR INTERNAL PROCEDURES AND 21 CFR PART 803.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86242 DIVERSATEK HEALTHCARE ZEPHR COMFORTEC PROBE FFT DIVERSATEK HEALTHCARE PHN15 005588 00816734022061

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown