QMS Everolimus Immunoassay 0380000Recalls & reported problems
Microgenics Corporation · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884883011687), received between Sep 14, 2017 and Sep 14, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Device Handling 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
Device problems
- Device Handling Problem1
- Use of Device Problem1
Patient problems
- Patient Problem/Medical Problem1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 14, 2017Use of Device Problem; Device Handling Problem; Use of Device Problem; Device Handling Problem
ERRONEOUS LOW EVEROLIMUS RESULTS WITH INJURY TO PATIENT. THE CUSTOMER STATED THAT THE INSTRUMENT KEEPS AUTO DILUTING THE TEST WHEN IT HAS NOT BEEN PROGRAMED TO DO SO. ACCORDING TO THE CUSTOMER, THE REAGENT VOLUME IS SET TO ZERO. ON INVESTIGATION, THE APPS MANAGER FOUND THAT ERRONEOUS LOW EVEROLIMUS WERE GENERATED DUE TO THIS ISSUE. THE RESULT WAS <2. THE PATIENT WAS REDRAWN TO CONFIRM THE RESULT. THE RESULTS MATCHED, BUT BOTH WERE INCORRECT. THE ERRONEOUS LOW RESULT WAS REPORTED OUT OF THE LABORATORY AND THE PHYSICIAN INCREASED DOSAGE OF EVEROLIMUS. THE PATIENT BECAME TOXIC, A SAMPLE WAS RUN AT A REFERENCE LABORATORY, AND ULTIMATELY THE PATIENT HAD TO HAVE DIALYSIS TO BRING THE LEVEL DOWN. THIS DID NOT RESULT IN DEATH.
Patient problems: Patient Problem/Medical Problem
MAUDE report 6866863 ↗
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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