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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATA INNOVATIONS LLC INSTRUMENT MANAGER SOFTWARE; CALCULATION/DATA PROCESSING MODULE, FOR CLINICAL USE
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DATA INNOVATIONS LLC INSTRUMENT MANAGER SOFTWARE; CALCULATION/DATA PROCESSING MODULE, FOR CLINICAL USE Back to Search Results
Model Number 8.17.30
Device Problem Installation-Related Problem (2965)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/09/2023
Event Type  malfunction  
Manufacturer Narrative
Upon investigation with the facility, it was determined that the site has a workflow intended to hold the first and second results of the hemoglobin a1c (hba1c).Based on the delta check, if the values are within 5%, the lowest value is released.If the values are not, both results are held for review.In this issue, the first two hemoglobin a1c (hgba1c) results were held based on rule (user facility programmed logic) configuration.When the third hgba1c result was processed, it was comparing to a result from january, which was not expected.During a review of the rule for the delta checks, it was determined that the "previous results" value rather than the "previous run" value was being used which caused the comparison to refer to an incorrect previous result.This is not a malfunction of the instrument manager medical device.This incident is due to an incorrect value being configured in the rule.The site implemented a workaround to manually check every result and subsequently terminated all testing on the analyzer.A patient impact statement has not yet been received from the site by data innovations and therefore patient impact has been unable to be determined.An investigation to determine patient impact is ongoing at the time of this report.
 
Event Description
A facility reported on 09 february 2023 that a rule for delta checking percentage difference between two hemoglobin (hba1c) results is not using the correct previous result for comparison.The facility reported that the previous results were causing incorrect results to be held.
 
Event Description
A facility reported on 09 february 2023 that a rule for delta checking percentage difference between two hemoglobin (hba1c) results is not using the correct previous result for comparison.The facility reported that the previous results were causing incorrect results to be held.
 
Manufacturer Narrative
Additional information: a representative from the facility provided additional information on the potential patient impact.The facility stated that there was no patient harm as a result of the use of an unexpected previous glycohemoglobin (hba1c) result.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.Information from original report: upon investigation with the facility, it was determined that the site has a workflow intended to hold the first and second results of the hemoglobin a1c (hba1c).Based on the delta check, if the values are within 5%, the lowest value is released.If the values are not, both results are held for review.In this issue, the first two hemoglobin a1c (hgba1c) results were held based on rule (user facility programmed logic) configuration.When the third hgba1c result was processed, it was comparing to a result from january, which was not expected.During a review of the rule for the delta checks, it was determined that the "previous results" value rather than the "previous run" value was being used which caused the comparison to refer to an incorrect previous result.This is not a malfunction of the instrument manager medical device.This incident is due to an incorrect value being configured in the rule.The site implemented a workaround to manually check every result and subsequently terminated all testing on the analyzer.A patient impact statement has not yet been received from the site by data innovations and therefore patient impact has been unable to be determined.An investigation to determine patient impact is ongoing at the time of this report.
 
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Brand Name
INSTRUMENT MANAGER SOFTWARE
Type of Device
CALCULATION/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
8026582782
MDR Report Key16527111
MDR Text Key311494718
Report Number1225673-2023-00001
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 06/30/2023
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 Number8.17.30
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 02/09/2023
Initial Date FDA Received03/10/2023
Supplement Dates Manufacturer Received02/09/2023
Supplement Dates FDA Received06/30/2023
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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