FDA.reportPublic FDA data

MAUDE MDR 866304

MDR report key
866304
Report number
2919016-2006-00019
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 INSUFFICIENT GROWTH (NO RESULTS) OCCURRED OVER PAST WEEK, ON GRAM POSITIVE OVERNIGHT PANELS WITH THE IDENTIFIED PROMPT LOT. ALTERNATE INOCULUM METHODS AND ALTERNATE PROMPT LOT WERE USED AND THE ACCOUNT HAD NO ISSUE WITH THEM. THERE WAS 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.