FDA.reportPublic FDA data

MAUDE MDR 8034463

MDR report key
8034463
Report number
3002769706-2018-00229
Event key
0
Event type
3
Date received
2018-11-02
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.JXA4161721006706520R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-11-020

Event Narratives#

D

Patient 1

A CUSTOMER IN THE (B)(6) REPORTED A FALSE NEGATIVE (NO GROWTH) RESULT FOR A NEQAS SURVEY SAMPLE ((B)(6)), WHEN USING THE CHROMID? CPS ELITE AGAR (LOT1006666680). THE EXPECTED RESULT OF THE NEQAS SAMPLE WAS STAPHYLOCOCCUS SAPROPHYTICUS. THE CUSTOMER TESTED A NEW SAMPLE ON THE SAME LOT OF CHROMID CPS ELITE AND ON COLUMBIA BLOOD AGAR. THE ISOLATE GREW WELL ON THE COLUMBIA BLOOD AGAR, BUT HAD NO GROWTH ON THE CHROMID CPS ELITE. THE CUSTOMER RECEIVED A NEW SAMPLE ((B)(6)) FROM NEQAS AND TESTED IT ON THE CHROMID CPS ELITE, AND THE RESULT WAS NO GROWTH. THERE WAS NO PATIENT INVOLVEMENT AS THE EVENT PERTAINED TO A SURVEY SAMPLE. A BIOM?RIEUX INTERNAL INVESTIGATION WILL BE INITIATED.