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Instrument Manager 8150011Recalls & 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 B180IMB028150), received between Apr 11, 2018 and Apr 11, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Loss of Data” (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.

Most reported problems

Device problems

  • Loss of Data1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionApr 11, 2018Loss of Data; Loss of Data

    USING THE "INSERT CODED ENTRY" ACTION IN THE TEST OR RUN WORKSHEET MAY RESULT IN AN INVALID CODE ENTERED INTO THE CODED ENTRY FIELD. THE RELEASED TESTS COULD GO OUT WITH INCORRECT RESULTS IF LAB TECH DOESN'T NOTICE THE CODED ENTRY CHANGED. WHEN USING "INSERT CODED ENTRY" ACTION FROM THE COMMAND BAR AN ENTRY SELECTED FROM THE INSERT CODED ENTRY SCREEN MAY UPDATE THE TEST OR RUN WORKSHEET CODED ENTRY FIELD, BUT WHEN YOU SAVE OR CLICK IN ANY OTHER CELL IN THE GRID IT CHANGES THE ENTRY TO A DIFFERENT CODED ENTRY VALUE. THIS ISSUE OCCURS UNDER THE FOLLOWING CONDITIONS ASSUMING CODED ENTRIES ARE BEING USED IN THE TEST OR RUN WORKSHEET: USER MUST BE IN THE TEST WORKSHEET OR RUN WORKSHEET. NOTE: THIS ISSUE DOES NOT OCCUR WHEN USER IS IN THE SPECIMEN WORKSHEET, USING A TEST WORKSHEET ONLY VIEW (I.E. NO FIELDS VISIBLE IN SPECIMEN WORKSHEET), OR USING MANUAL RESULTS ENTRY OR CELL COUNTER. USER MUST HAVE THE CURSOR IN A CODED ENTRY FIELD (PATIENT COMMENT(S), SPECIMEN REVIEWER COMMENT(S), SPECIMEN COMMENT(S), RESULT, TEST REVIEWER COMMENT(S) OR TEST COMMENT(S)). NOTE: THE CURSOR MUST BE IN THE FIELD AND IN "EDIT MODE" (I.E. THE CURSOR WILL BE FLASHING). THIS ISSUE WILL NOT OCCUR IF THE CODED EN

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7421388 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.