FDA.reportPublic FDA data

MAUDE MDR 2169950

MDR report key
2169950
Report number
2122870-2011-02214
Event key
0
Event type
3
Date of event
2008-12-19
Date received
2011-07-15
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
MS NORA ZEROUNIAN
Address
250 S KRAEMER BLVD BREA CA 92821 US
Phone
714-714-7149
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ACCESS 2 IMMUNOASSAY SYSTEMBECKMAN COULTER, INC.CGNNA81600NNAY Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-07-150

Event Narratives#

D

Patient 1

CUSTOMER REPORTED ERRONEOUS TEST RESULTS FOR VITAMIN B12 WERE OBTAINED WHILE USING AN ACCESS 2 IMMUNOASSAY SYS. REPORTED IMPRECISION WITH THE VITAMIN B12 ASSAY OCCURRING WITH THE LAST TESTS OF THE REAGENT PACK. IT IS UNK IF ERRONEOUS RESULTS WERE REPORTED OUT OF THE LAB. AFFECT TO PT TREATMENT IS UNK. NO REPORTS OF DEATH OR SERIOUS INJURY AS A RESULT OF THIS EVENT. THIS EVENT REPRESENTS EVENT 11 OF 17 EVENTS REPORTED BY THIS CUSTOMER FOR 13 PT SAMPLES.

N

Patient 1

THE CUSTOMER RUNS 3 LEVELS OF QC AT THE BEGINNING OF EVERY REAGENT PACK AND IT IS WITHIN THE CUSTOMER'S SPECS. CUSTOMER STATES THE 48TH THROUGH THE 50TH TEST OF EACH REAGENT PACK IS ERRONEOUSLY HIGH. ISSUE IS ISOLATED TO ONLY THIS ASSAY. THE FIELD SVC ENGINEER PERFORMED A SYS CHECK WHICH PASSED. THE INSTRUMENT WAS UP TO DATE WITH ALL MAINTENANCE. THE INVESTIGATION DID NOT CONFIRM CUSTOMER'S STATEMENT THAT ALL ERRONEOUS RESULTS WERE PERFORMED AT THE END OF THE REAGENT PACKAGE. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(4) 2008 AND (B)(4) 2010 OF COMPLAINTS FOR ADD'L REPORTABLE EVENTS. THIS MDR REPRESENTS EVENT 11 OF 17 REPORTED BY THIS CUSTOMER. THE 17 RELATED MDRS THAT HAVE BEEN REPORTED ARE: MDR 2122870-2011-01253, 02205, 02206, 02207, 02208, 02209, 02210, 02211, 02212, 02213, 02215, 02216, 02217, 02218, 02219, 02220, 02221.