Instrument Manager 817Recalls & reported problems
Data Innovations LLC · Instrument Manager is a stand-alone software application that provides connectivity between laboratory instruments and Laboratory Information Systems, aiding the flow of laboratory information, including test orders and results, specimen information, and patient information. Instrument Manager also provides data management functions that aid in the interpretation and management of laboratory results. Instrument Manager is a software package intended to be used by trained laboratory personnel as an aid in laboratory instrument interfacing and laboratory data management. · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI B180IMB028170), received between Oct 20, 2023 and Oct 20, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Unauthorized Access to Computer System” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Unauthorized Access to Computer System1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 20, 2023Unauthorized Access to Computer System; Unauthorized Access to Computer System
A REPRESENTATIVE FROM THE DISTRIBUTOR REPORTED ON (B)(6) 2023, THAT AFTER A USER FACILITY COMPLETED AN UPGRADE OF INSTRUMENT MANAGER SOFTWARE, THE LDAP AUTHENTICATION METHOD ALLOWED CONFIGURED USERS TO LOG IN WITH INCORRECT OR MISSING PASSWORDS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17981328 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.