HealthMyne QIDS 3.0Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI B198HM0030), received between Feb 12, 2018 and Feb 12, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Patient Data Problem” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2018Patient Data Problem; Patient Data Problem

  MALFORMED HL7 PATIENT IDS WERE SENT TO THIS MEDICAL DEVICE RESULTING IN DIFFERENT PATIENT'S STUDIES BEING IDENTIFIED AS THE SAME PATIENT. NONE OF THESE STUDIES WERE READ OR USED FOR DIAGNOSIS. THE ISSUE WAS DISCOVERED DURING A ROUTINE SERVICE CHECK, CUSTOMER WAS CONTACTED, AND THE ISSUE WAS CONTAINED.

  Patient problems: Not Applicable

  MAUDE report 7264643 ↗