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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CERNER CORPORATIONLABORATORY INFORMATION SYSTEM

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CERNER CORPORATION LABORATORY INFORMATION SYSTEM   Back to Search Results
Event Date 04/28/2006
Event Type  No Answer Provided  
Event Description

Microbiology set up a program within the cerner computer system to automate the reporting system for hsv (herpes simplex virus)testing. The system was tested with the assistance of cerner and found to be working appropriately. The new system was operational for approximately 3 weeks when it was determined that the first word of the sentence, "no" was inappropriately dropping off of the following sentence: "no herpes simplex virus type 1 or herpes simplex virus type 2 detected by dna amplification. " as such, two of five patients were incorrectly informed that they had hsv before the error was detected. One had started an antiviral creme treatment. The other three did not have follow-up visits until after the correct results were determined. Cerner has looked at the program and has not provided an answer for the system issue. In the interim, the previous manual review and entry process is being used.

 
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Type of DeviceLABORATORY INFORMATION SYSTEM
Manufacturer (Section F)
CERNER CORPORATION
2800 rockcreek parkway
kansas city MO 64117
Manufacturer (Section D)
CERNER CORPORATION
2800 rockcreek parkway
kansas city MO 64117
Device Event Key740830
MDR Report Key753029
Event Key717764
Report Number753029
Device Sequence Number1
Product CodeLNX
Report Source User Facility
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 07/10/2006
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/10/2006
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator Invalid Data
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/10/2006
Event Location Outpatient DIAGNOSTIC Facility
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided

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