FDA.reportPublic FDA data

MAUDE MDR 866302

MDR report key
866302
Report number
2919016-2006-00020
Event key
0
Event type
3
Date of event
2006-09-03
Date received
2006-09-27
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
JOSE UNTALAN
Address
2040 ENTERPRISE BLVD. WEST SACRAMENTO CA 95691 US
Phone
916-916-9163
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1MICROSCAN PROMPT INOCULATION SYSTEM - DPANEL INOCULATING SUPPLIESDADE BEHRING, INC.JSDNAB1026-10D20071127NRN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12006-09-270

Event Narratives#

D

Patient 1

ACCOUNT REPORTED TO DADE BEHRING THAT 20 OF 85 MICROSCAN GRAM-POSITIVE AND GRAM-NEGATIVE PANELS WERE YIELDING INSUFFICIENT GROWTH (NO RESULTS). RESULTS WERE ASSOCIATED WITH IDENTIFIED PROMPT LOT. NO REPORT OF INJURY OR ILLNESS ASSOCIATED WITH THIS ISSUE.

N

Patient 1

EVALUATION: IN-HOUSE TESTING PERFORMED AND CONFIRMED INSUFFICIENT GROWTH ISSUE WITH CUSTOMER PROVIDED SAMPLES AND ALSO WITH RETENTION SAMPLES. CONCLUSION: INVESTIGATION HAS NOT BEEN COMPLETED.