MAUDE MDR 20391

MDR report key
20391
Report number
MW1005493
Event key
0
Event type
3
Date of event
1995-02-06
Date received
1995-03-17
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1BBL SEPTI-CHEKMICROBIOLOGIC CULTURE MEDIA (DIAGNOSIS)BECTON DICKINSON MICROBIOLOGY SYSTEMSJSJ43431810518K41KBNN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
11995-03-170

Event Narratives#

D

Patient 1

IN 8/94, RPTR'S LABORATORY NOTED A CLUSTER OF CANDIDA GUILLERMONDII ISOLATED FROM BLOOD CULTURES. THIS ORAGNISM IS RARELY ISOLATED FROM BLOOD CULTURES. FURTHER, THE ORGANISM WAS NEVER ISOLATED FROM MORE THAN ONE BLOOD CULTURE BOTTLE AND THE PTS FROM WHOM THE ORGANISM WAS ISOLATED DID NOT HAVE A CLINICAL PICTURE OF FUNGAL SEPSIS OR RISK FOR FUNGAL DISEASE. IN OTHER WORDS, THESE ISOLATES SEEMED TO BE CONTAMINANTS. RPTR CONTACTED MFR TO ALERT THEM OF THIS CONCERN THAT THEY HAD A LOW LEVEL CONTAMINATION OF THEIR AEROBIC BLOOD CULTURE SYSTEM (BOTTLES OR SLIDE CHAMBERS). AT THE TIME, RPTR WAS ASSURED THAT THERE HAD BEEN NO OTHER COMPLAINTS. HOWEVER, IN 11/94, RPTR RECEIVED AN "IMPORTANT PRODUCT NOTICE" REGARDING SPORADIC RPTR CONTAMINATION OF THEIR SUBCULTURE SLIDES. UNFORTUNATELY, IN SPITE OF MFR'S ASSURANCES TO THE CONTRARY, IT APPEARS THAT THEY HAVE NOT FIXED THE PROBLEM. EARLIER THIS MONTH, RPTR ENCOUNTERED A CANDIDA GUILLERMONDII ISOLATE FROM A SINGLE AEROBIC BOTTLE THAT WAS MORPHOLOGICALLY AND BIOCHEMICALLY IDENTICAL TO THOSE ENCOUNTERED LAST SUMMER. THE ISOLATE WAS CONSIDERED A CONTAMINANT BY THE PT'S PRIVATE INTERNIST AS THE PT HAD NO RISK FACTORS FOR FUNGAL INFECTION AND DID NOT HAVE A CLINICAL COURSE COMPATIBLE WITH SYSTEMIC FUNGAL INFECTION. RPTR HAS AGAIN CONTACTED THE MFR WITH HIS CONCERNS ABOUT CONTINUING CONTAMINATION OF THEIR PRODUCT. (*)