MAUDE Adverse Event Report: DATA INNOVATIONS LLC INSTRUMENT MANAGER SOFTWARE; CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE

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 06/05/2023

Event Type  malfunction  

Event Description

A representative from the reseller reported on 05 jun 2023 that when certain immunoassay tests such as crp, ck, and bhcg have results above linearity and therefore require dilution, only the initial result with the ">" result is reported to the laboratory information system (lis) instead of the diluted results.

Manufacturer Narrative

A collaborative investigation was completed by data innovations llc (manufacturer), abbott laboratories (distributor), and lafayette general medical center (facility).Investigation with the facility determined that when certain immunoassay tests such as crp, ck, and bhcg have results above linearity and therefore require dilution, only the initial result with the ">" result is reported to the laboratory information system (lis) instead of the diluted results.During review of a format upper limit reporting rule (user facility programmed logic), it was determined that the upper limit formatting clinical reportable range (crr) table (representing the highest value that an instrument can report as a result with dilution) was not defined correctly.This is not a malfunction of instrument manager medical device.The root cause is due to incorrect values configured in the upper limit reporting rule.The facility has since corrected the rule.A patient impact statement has not yet been received by data innovations and therefore patient impact has been unable to be determined at this time.An investigation to determine potential patient impact is ongoing at the time of this report.

Event Description

A representative from the reseller reported on 05 jun 2023 that when certain immunoassay tests such as crp, ck, and bhcg have results above linearity and therefore require dilution, only the initial result with the ">" result is reported to the laboratory information system (lis) instead of the diluted results.

Manufacturer Narrative

Additional information: a representative from the facility provided additional information on the potential patient impact.The facility stated that after a review of the data, the investigation concluded there was no negative impact to patient care as a result of the initial result with the ">" being reported to the laboratory information system (lis) instead of the diluted results.The results verified with a ">" value were corrected once the dilution results were completed.Based on 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: a collaborative investigation was completed by data innovations llc (manufacturer), abbott laboratories (distributor), and lafayette general medical center (facility).Investigation with the facility determined that when certain immunoassay tests such as crp, ck, and bhcg have results above linearity and therefore require dilution, only the initial result with the ">" result is reported to the laboratory information system (lis) instead of the diluted results.During review of a format upper limit reporting rule (user facility programmed logic), it was determined that the upper limit formatting clinical reportable range (crr) table (representing the highest value that an instrument can report as a result with dilution) was not defined correctly.This is not a malfunction of instrument manager medical device.The root cause is due to incorrect values configured in the upper limit reporting rule.The facility has since corrected the rule.A patient impact statement has not yet been received by data innovations and therefore patient impact has been unable to be determined at this time.An investigation to determine potential patient impact is ongoing at the time of this report.

• 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 Key: 17243166
• MDR Text Key: 318304431
• Report Number: 1225673-2023-00004
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/12/2023

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 Number: 8.17.30
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/05/2023
• Initial Date FDA Received: 06/30/2023
• Supplement Dates Manufacturer Received: 06/05/2023
• Supplement Dates FDA Received: 07/12/2023
• Patient Sequence Number: 1