FDA.reportPublic FDA data

MAUDE MDR 904640

MDR report key
904640
Report number
2919016-2007-00005
Event key
0
Event type
3
Date of event
2007-08-15
Date received
2007-08-28
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
RICH LAGUNA
Address
2040 ENTERPRISE BLVD. WEST SACRAMENTO CA 95691 US
Phone
916-916-9163
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1DRIED POS MIC TYPE 23ANTIMICROBIC SUSPECT. PANEL: GRAM POSDADE BEHRING, INC.LTTNAB1017-2072008-06-19NRN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12007-08-280

Event Narratives#

D

Patient 1

CUSTOMER REPORTED S. AUREUS ISOLATE OXACILLIN (OX) MIC DISCREPANCY. THEY OBTAINED OXACILLIN-SUSCEPTIBLE RESULTS ON THE DRIED POS MIC TYPE 23 PANEL AND OXACILLIN-RESISTANT RESULTS ON SECONDARY METHODS THAT WERE ALSO PERFORMED FOR THE CLINICAL ISOLATE. RESULTS WERE REPORTED TO THE PHYSICIAN AFTER PATIENT TREATMENT WAS STARTED. IT IS UNKNOWN IF TREATMENT WAS ALTERED BASED ON THE SUSCEPTIBILITY TEST RESULTS. NO REPORTS OF ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THE DISCREPANT RESULT BEING OBTAINED. THE CAUSE OF THE OXACILLIN SUSCEPTIBLE RESULTS IS UNKNOWN.

N

Patient 1

EVALUATION: METHOD: ROUTINE MONITORING OF COMPLAINT HISTORY AND PERFORMANCE TRENDS TO ENSURE PERFORMANCE IS WITHIN CLAIMS. REQUESTED ADDITIONAL INFORMATION TO DETERMINE IF MALFUNCTION OCCURRED. PRODUCT IS WITHIN PERFORMANCE CLAIMS.