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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, PRODUCT CODE:
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DATA INNOVATIONS LLC INSTRUMENT MANAGER SOFTWARE; CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE, PRODUCT CODE: Back to Search Results
Model Number 8.14.10
Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Electrolyte Imbalance (2196)
Event Date 01/05/2022
Event Type  Death  
Event Description
A representative from the reseller reported on (b)(6) 2022 that on (b)(6) 2022, the laboratory information system (lis) had received a result from instrument manager (im) that did not include the critical co2 result.The critical co2 result was held as required by rules for verification purposes.When the results were verified by the medical technician, only the potassium result from the panel was released.A second action was subsequently taken by the medical technician to release the remainder of the panel including the critical co2 result from instrument manager to the patient chart.This resulted in a delay in reporting the results which may have contributed to the patient's death.Internal investigation at the customer site determined this was as a result of user error, and not a malfunction of instrument manager.
 
Event Description
A representative from the reseller reported on (b)(6) 2022 that on (b)(6) 2022, the laboratory information system (lis) had received a result from instrument manager (im) that did not include the critical co2 result.The critical co2 result was held as required by rules for verification purposes.When the results were verified by the medical technician, only the potassium result from the panel was released.A second action was subsequently taken by the medical technician to release the remainder of the panel including the critical co2 result from instrument manager to the patient chart.This resulted in a delay in reporting the results which may have contributed to the patient's death.Internal investigation at the customer site determined this was as a result of user error, and not a malfunction of instrument manager.
 
Manufacturer Narrative
An additional information request was received on (b)(6) 2022, requesting additional information regarding the investigation and whether the investigation had been completed.See attached for a copy of the additional information request.A collaborative investigation completed by data innovations (manufacturer), roche diagnostics (distributor) and the north shore health systems core lab (customer) concluded that the adverse event was the result of user error.On (b)(6) 2022, data innovations was notified of an adverse incident by a distributor of our product (instrument manager).An initial inquiry was directed at a data innovations distributor regarding a partial release of data out of instrument manager (im).Specifically, why a co2 was delayed in being released.The initial incident occurred on (b)(6) 2022.Further investigation by data innovations with the distributor and customer indicated that the incident may have contributed to a patient death.During the investigation data innovations examined the im specimen event log (sel) and noted that there was a gap in time between when the testing was completed and when the results were released to im and subsequently reported out.The examination of the sel indicated that the order crossed at 10:51:28 am, the result was received by im at 11:59:35am, a single result (potassium) was released at 12:00:42pm and the remainder of the panel at 12:04:34pm.The findings of the sel examination were confirmed with both the distributor and the customer.The customer when questioned indicated that the initial lag in time was the result of the user not releasing the results.Further review of the sel to determine the main cause of the initial inquiry indicated that only the potassium was initially released by the user, and the remainder of the panel was released four minutes later by the user.The remainder of the panel included the co2 result which the customer indicated was abnormal and the delay in the release may have contributed to the patient death.Data innovations concluded with the distributor and customer that this was not a malfunction of im and was the result of user error.
 
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Brand Name
INSTRUMENT MANAGER SOFTWARE
Type of Device
CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL 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 Key13338293
MDR Text Key284344103
Report Number1225673-2022-00001
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 Distributor
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 02/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Model Number8.14.10
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/11/2022
Initial Date FDA Received01/24/2022
Supplement Dates Manufacturer Received01/11/2022
Supplement Dates FDA Received02/14/2022
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Death;
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