FDA.reportPublic FDA data

MAUDE MDR 7164052

MDR report key
7164052
Report number
3002769706-2018-00002
Event key
0
Event type
3
Date received
2018-01-04
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MRS. ELLEN WELTMER
Address
595 ANGLUM ROAD ST. LOUIS MO 63042 US
Phone
314-314-3147
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CHROMID? MRSA SMARTCHROMID? MRSA SMARTBIOM?RIEUX SAJSO4130511006023560R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-01-040

Event Narratives#

D

Patient 1

A CUSTOMER FROM (B)(6) REPORTED TO BIOM?RIEUX A FALSE NEGATIVE RESULT FOR A (B)(6) STRAIN ON A CHROMID? MRSA SMART (LOT 1006023560) PLATE. THE CUSTOMER STATED A SPECIFIC STRAIN OF STAPHYLOCOCCUS AUREUS DID NOT GROW ON THE CHROMID? MRSA SMART PLATE. THE STRAIN WAS CULTURED ON CHROMID? MRSA SMART, CHROMID? S. AUREUS ELITE, AND BLOOD AGAR. THE S. AUREUS ONLY GREW ON THE BLOOD AGAR. THE CUSTOMER THEN PERFORMED DISC TESTING AND FOUND THE STRAIN TO BE CEFOXITIN RESISTANT. IT WAS THEN CULTURED FROM THE ORIGINAL SAMPLE TUBE TO A NEW MRSA SMART PLATE AND A BD CHROMAGAR MRSA PLATE, AND THERE WAS NO GROWTH ON THE MRSA SMART PLATE AND FULL GROWTH ON THE CHROMAGAR MRSA PLATE. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOM?RIEUX THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. A BIOM?RIEUX INTERNAL INVESTIGATION WILL BE INITIATED.