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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATA INNOVATIONS LLC INSTRUMENT MANAGER SOFTWARE; CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE,
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DATA INNOVATIONS LLC INSTRUMENT MANAGER SOFTWARE; CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE, Back to Search Results
Model Number 8.17.20
Device Problem Insufficient Information (3190)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/05/2022
Event Type  malfunction  
Event Description
A laboratory user reported on (b)(6) 2022 that a rule to suppress duplicate ordered tests and set the run count is only firing on the second order containing the collection date/time.The rule, as it is written, should fire on both orders.Initial investigation of the instrument manager specimen management module event log was unable to determine why the rule does not fire on the first transmission.There was no patient harm due to the orders still being processed however additional reagent was used on the duplicate order.Investigation has been unable to reproduce the issue and therefore has not yet been determined if this is a malfunction of the instrument manager software.
 
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Brand Name
INSTRUMENT MANAGER SOFTWARE
Type of Device
CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE,
Manufacturer (Section D)
DATA INNOVATIONS LLC
463 mountain view drive
colchester VT 05446
Manufacturer Contact
sara shaw
463 mountain view drive
colchester, VT 05446
8026582850
MDR Report Key13446590
MDR Text Key296045702
Report Number1225673-2022-00002
Device Sequence Number1
Product Code JQP
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 02/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number8.17.20
Initial Date Manufacturer Received 01/05/2022
Initial Date FDA Received02/03/2022
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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