FDA.reportPublic FDA data

MAUDE MDR 7374737

MDR report key
7374737
Report number
3002769706-2018-00049
Event key
0
Event type
3
Date received
2018-03-27
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
MS. ELLEN WELTMER
Address
100 RODOLPHE STREET DURHAM NC 27712 US
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ETEST? DAPTOMYCIN DPC 256 WW F100ETEST? DAPTOMYCIN DPC 256 WW F100BIOMERIEUX SAJWY5350181004343910R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-03-270

Event Narratives#

D

Patient 1

A CUSTOMER FROM (B)(6) REPORTED OUT OF RANGE LOW RESULTS FOR INTERNAL QUALITY CONTROLS (QC) IN ASSOCIATION WITH ETEST? DAPTOMYCIN DPC 256 WW F100 (REFERENCE 535018) LOT 1004343910. THE CUSTOMER STATED THAT WHEN THEIR QC IS WITHIN RANGE IT IS ALWAYS AT THE VERY LOWEST END OF THE QC RANGE FOR BOTH THE STAPHYLOCOCCUS AUREUS ATCC? 29213 AND ENTEROCOCCUS FAECALIS ATCC? 29212. THE CUSTOMER REPORTED THAT WHEN THE QC IS OUT OF RANGE, IT IS ALWAYS LOWER THAN EXPECTED. THE CUSTOMER REPORTED THAT RESULTS WERE DELAYED AT LEAST 72 HOURS FOR TWO (2) PATIENTS (WITH VRE IN THE BLOOD) DUE TO THE DAPTOMYCIN QC FAILING AT LEAST TWICE. 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 A PATIENT'S STATE OF HEALTH. A BIOM?RIEUX INTERNAL INVESTIGATION WILL BE INITIATED.