FDA Adverse Event Malfunction Summary report: N

LEXICOR

MDR report key: 551872 · Received August 24, 2004

Report

Report Number
MW1033470
Event Type
Malfunction
Date Received
August 24, 2004
Date of Event
October 7, 2002
Report Date
August 11, 2004
Manufacturer
LEXICOR
Product Code
GWQ
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
CA, US
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

THIS PT SUFFERED A MILD CONCUSSION. A CLINICAL PSYCHOLOGIST USED THESE QEEG TEST RESULTS TO DIAGNOSE A MILD TRAUMATIC BRAIN DAMAGE. NO MRI WAS OBTAINED. NO NEUROLOGICAL EXAMINATION WAS UNDERTAKEN. THE USE OF THE TEST IN THIS WAY SEEMS UNWARRANTED AND DANGEROUS. IN THIS CASE IT MAY HAVE CAUSED AN ERRONEOUS DIAGNOSIS. THE DEVICE PURPORTS TO PROVIDE HIGHLY ACCURATE DIAGNOSTIC RESULTS FOR IDENTIFYING MILD TRAUMATIC BRAIN INJURY AND FOR ATTENTION DEFICIT HYPERACTIVITY DISORDER. THIS WILL MISLEAD A CLINICIAN INTO BELIEVING THAT THE TEST CAN BE USED AS A DIAGNOSTIC DEVICE IN THAT WAY. AFTER REVIEWING THE LITERATURE CITED IN THESE REPORTS, THEY APPEAR TO FAIL TO PROVIDE SUFFICIENT COGENT INFO TO ALLOW SUCH A CONCLUSION. THE STUDIES ARE EITHER NOT PROSPECTIVE, OR NOT OUTCOME STUDIES AT ALL, OR FAIL TO ADDRESS THE KEY ISSUES. THEY OVERLOOK OTHER STUDIES THAT SHOW THE OPPOSITE RESULTS (E.G 52% FALSE POSITIVES), OR SHOW POOR DIAGNOSTIC CLASSIFICATION BY SUCH A TEST. A NON-PHYSICIAN (A SPEECH THERAPIST) GENERATED THESE STUDIES AND CREATES THESE REPORTS. NO KNOWLEDGEABLE PHYSICIAN EXPERT PROVIDES ANY FURTHER MEDICAL DIAGNOSTIC REPORT. ANOTHER NON-PHYSICIAN (A CLINICAL PSYCHOLOGIST) CITED THESE RESULTS TO DIAGNOSE BRAIN DAMAGE. THE RESULT IS CONFUSING BECAUSE IT APPEARS TO PROVIDE DIAGNOSTIC DETERMINATIONS WHEN THERE IS A POOR BASIS IN THE LITERATURE FOR MAKING SUCH AN AUTOMATED DIAGNOSIS. THIS SEEMS LIKE A DANGEROUS COMBINATION OF A MACHINE THAT PURPORTS RESULTS BEYOND WHAT IT CAN DO, AND A USER WHO IS NOT QUALIFIED BY SKILL, KNOWLEDGE, ABILITY, TRAINING OR EXPERIENCE TO READ EEGS OR MAKE SUCH A DIAGNOSIS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 LEXICOR NEUROSEARCH-24 GWQ LEXICOR * *

Patients

Seq Age Sex Outcome Treatment
1 31 YR Other