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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 CLINCIAL USE, PRODUCT CODE
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DATA INNOVATIONS LLC INSTRUMENT MANAGER SOFTWARE; CALCULATOR/DATA PROCESSING MODULE, FOR CLINCIAL USE, PRODUCT CODE Back to Search Results
Model Number 8.17.10
Device Problem Installation-Related Problem (2965)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/22/2022
Event Type  malfunction  
Event Description
A facility reported on (b)(6) 2022 that a rule (user facility programmed logic) was suppressing comments for critical results after the rule fired.When the comment is removed, the technician may not see the critical result in the worklist and therefore providers may not be notified of the critical result.
 
Manufacturer Narrative
Upon investigation, it was determined that a panel with multiple tests (whole blood chem panel) was run; 2 of the results were determined to be critical based upon the pre-defined critical ranges.The facility has rules (user facility programmed logic) that are configured to add a specimen comment (containing a "template" to capture the provider called, data/time of call, and initials of the tech that called in the critical result) if the result is within the pre-defined critical ranges.In this case, one specimen comment was added indicating that 2 tests were critical.The sample was then rerun for 1 of the 2 critical tests.The result from the rerun was determined to again be critical.Based on the current configuration of the rule, the initial specimen comment (identifying 2 results as critical) was nulled out by the rerun and a new specimen comment was generated indicating that only one test result was critical.Upon review of the rules, the rule was determined to be working as configured at the time of implementation.The investigation also determined that this was a workflow that was not planned for when the rules were configured.The workflow is when a test is rerun or a repeat test is run due to an error code, the subsequent result may be returned without a specimen comment.This is not a malfunction of instrument manager.This incident is due to the configuration of the rules within the software and not addressing all potential use cases for the workflow with critical results.The facility reported that there is a potential of patient harm when this issue happens due to the possibility that the technician may not see the critical result in the worklist, and therefore the provider may not be notified timely.When the critical result is identified by the technician, the technician can manually enter the specimen comment containing the required information.Investigation into the determination if there was actual patient impact is ongoing at the time of this report.
 
Event Description
A facility reported on (b)(6) 2022 that a rule (user facility programmed logic) was suppressing comments for critical results after the rule fired.When the comment is removed, the technician may not see the critical result in the worklist and therefore providers may not be notified of the critical result.
 
Manufacturer Narrative
Additional information: a representative from the facility provided additional information on the potential patient impact.The facility stated that a supervisor reviews all critical results regularly to confirm that all critical results have been communicated to the provider.No critical result communications have been missed and there is no patient harm.Based on the additional patient impact information provided by the facility, two data values have been updated in section h6.First, the health effect - clinical code has been updated to 4582: no clinical signs, symptoms, or conditions.Second, the health effect - impact code has been updated to 2199 - no health consequences or impact.Upon investigation, it was determined that a panel with multiple tests (whole blood chem panel) was run; 2 of the results were determined to be critical based upon the pre-defined critical ranges.The facility has rules (user facility programmed logic) that are configured to add a specimen comment (containing a "template" to capture the provider called, data/time of call, and initials of the tech that called in the critical result) if the result is within the pre-defined critical ranges.In this case, one specimen comment was added indicating that 2 tests were critical.The sample was then rerun for 1 of the 2 critical tests.The result from the rerun was determined to again be critical.Based on the current configuration of the rule, the initial specimen comment (identifying 2 results as critical) was nulled out by the rerun and a new specimen comment was generated indicating that only one test result was critical.Upon review of the rules, the rule was determined to be working as configured at the time of implementation.The investigation also determined that this was a workflow that was not planned for when the rules were configured.The workflow is when a test is rerun or a repeat test is run due to an error code, the subsequent result may be returned without a specimen comment.This is not a malfunction of instrument manager.This incident is due to the configuration of the rules within the software and not addressing all potential use cases for the workflow with critical results.The facility reported that there is a potential of patient harm when this issue happens due to the possibility that the technician may not see the critical result in the worklist, and therefore the provider may not be notified timely.When the critical result is identified by the technician, the technician can manually enter the specimen comment containing the required information.Investigation into the determination if there was actual patient impact is ongoing at the time of this report.
 
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Brand Name
INSTRUMENT MANAGER SOFTWARE
Type of Device
CALCULATOR/DATA PROCESSING MODULE, FOR CLINCIAL USE, PRODUCT CODE
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 Key15655454
MDR Text Key306821366
Report Number1225673-2022-00012
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,Followup
Report Date 11/28/2022
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 Number8.17.10
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 09/22/2022
Initial Date FDA Received10/21/2022
Supplement Dates Manufacturer Received09/22/2022
Supplement Dates FDA Received11/28/2022
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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