FDA.reportPublic FDA data

MAUDE MDR 8062054

MDR report key
8062054
Report number
3002769706-2018-00237
Event key
0
Event type
3
Date received
2018-11-12
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. DEBRA BROYLES
Address
595 ANGLUM ROAD HAZELWOOD MO 63042 US
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CHROMID? CPS ELITECHROMID? CPS ELITEBIOMERIEUX S.A.JXA4161721006666680R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-11-120

Event Narratives#

D

Patient 1

A CUSTOMER IN THE (B)(6) REPORTED A NO RESULT (NO GROWTH) FOR AN EXTERNAL QUALITY CONTROL (EQA) SAMPLE (NEQAS DISTRIBUTION 4341 SAMPLE 4569) ON CHROMID? CPS ELITE AGAR (LOT 1006606560). THE EXPECTED RESULT OF THE EQA SAMPLE WAS STAPHYLOCOCCUS SAPROPHYTICUS. WHEN THE CUSTOMER OBTAINED THE RESULTS OF THE NEQAS SURVEY, THEY ASKED FOR A REPEAT SAMPLE. THE CUSTOMER THEN TESTED A SECOND LOT (100666680) OF CHROMID CPS ELITE, AND ALSO CULTURED THE EQA SAMPLE ONTO BLOOD AGAR AND CLED (CYSTINE LACTOSE ELECTROLYTE DEFICIENT) MEDIUM. THE RESULT WAS NO GROWTH ON CHROMID CPS ELITE, WHILE STAPHYLOCOCCUS SAPROPHYTICUS GREW ON BOTH BLOOD AGAR AND CLED. A BIOM?RIEUX INTERNAL INVESTIGATION WILL BE INITIATED.