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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 V8.16
Device Problem No Apparent Adverse Event (3189)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/07/2019
Event Type  malfunction  
Event Description
A data innovations' customer reported that quality control rules configured to fire when there was a quality control violation were not consistently firing (running).If a rule is created and has at least three level of rules, some of the third level rules will not fire (run).This can result in a result that should have been held due to a quality control violation being erroneously released.The customer who reported the incident has stated these rules were never implemented in a live system, and no patients were harmed.Investigation is continuing to determine root cause of the issue.
 
Event Description
A data innovations' customer reported that quality control rules configured to fire when there was a quality control violation were not consistently firing (running).If a rule is created and has at least three level of rules, some of the third level rules will not fire (run).This can result in a result that should have been held due to a quality control violation being erroneously released.The customer who reported the incident has stated these rules were never implemented in a live system, and no patients were harmed.Investigation is continuing to determine root cause of the issue.
 
Manufacturer Narrative
Data innovations investigation into the root cause of this incident is complete.There was no malfunction of instrument manager.This issue involved the user configuration of a rules set that had multiple layers of rules.Due to the way the rules set was configured, under certain circumstances, the rule would not fire as expected, but under other circumstances the rule fired as expected.The device was functioning as designed, and was not a non-conformance.The customer has been provided with a new rule design, and the problem has been resolved.The rule had not been made live, the issue was caught in a test environment, and no patients were harmed.
 
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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
120 kimball avenue
suite 100
south burlington VT 05403
MDR Report Key9298388
MDR Text Key219565374
Report Number1225673-2019-00010
Device Sequence Number1
Product Code JQP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Remedial Action Modification/Adjustment
Type of Report Initial,Followup
Report Date 11/11/2019
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 Operator Health Professional
Device Model NumberV8.16
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/07/2019
Initial Date FDA Received11/08/2019
Supplement Dates Manufacturer Received10/07/2019
Supplement Dates FDA Received11/11/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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