FDA.reportPublic FDA data

MAUDE MDR 2655423

MDR report key
2655423
Report number
2122870-2012-01600
Event key
0
Event type
3
Date of event
2012-06-19
Date received
2012-07-13
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 DUNG NGUYEN
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 FOLATE ASSAYACID, FOLIC, RADIOIMMUNOASSAYBECKMAN COULTER, INC.CGNNAA14207112788Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-07-130

Event Narratives#

D

Patient 1

BECKMAN COULTER INC. INTERNAL INVESTIGATION RESULTS INDICATED THAT THREE COMMERCIALLY RELEASED ACCESS FOLATE ASSAY CALIBRATOR LOTS RECOVERED HIGHER THAN COMPARABLE BECKMAN COULTER INC. REFERENCE CALIBRATOR VALUES. THESE LOTS SIMULATED STABILITY RESULTS EQUALED OR EXCEEDED UPPER STABILITY ACCEPTANCE LIMITS AS WELL. THROUGH BECKMAN COULTER INC. INTERNAL INVESTIGATION, IT WAS ALSO IDENTIFIED THAT A FOURTH COMMERCIALLY RELEASED ACCESS FOLATE ASSAY CALIBRATOR LOT, FROM A SECOND BECKMAN COULTER INC. PRODUCT CODE, DID NOT SATISFY SPECIFIC PRODUCT STABILITY TIME POINT THE TWO ACCESS FOLATE ASSAY CALIBRATOR PRODUCT CODES INVOLVED WITH THIS EVENT POSSESSED IDENTICAL FORMULATIONS. THIS REPORT REPRESENTS THE ELEVATED DOSE RECOVERY AND SIMULATED STABILITY RESULTS EXPERIENCED BY ONE OF THE ACCESS FOLATE ASSAY CALIBRATOR PRODUCT CODES, A14207, WITH LOT NUMBER 112788. AN EVALUATION OF INTERNAL ASSESSMENT DATA REVEALED THAT THIS LOT'S RECOVERING DOSE WAS APPROXIMATELY EIGHTEEN PERCENT HIGHER THAN INTERNAL FOLATE REFERENCE CALIBRATORS. FURTHER INVESTIGATION ALSO INDICATED THAT ACCESS FOLATE ASSAY CALIBRATOR LOT 112788 SIMULATED STABILITY RESULTS WERE PROJECTED TO EXCEED THE STABILITY TESTING REQUIREMENTS OF TWELVE PERCENT. NO PATIENT RESULTS WERE INVOLVED IN THIS SPECIFIC EVENT AND HENCE THERE WAS NO DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT.

N

Patient 1

THIS ISSUE IS CURRENTLY BEING INVESTIGATED BY BECKMAN COULTER INC. DEVICE EVALUATION WAS PERFORMED AS PART OF INITIAL EVENT INVESTIGATION AND IS ONGOING AS PART OF FURTHER INVESTIGATIVE ACTIVITIES. THE CAUSE OF THIS EVENT IS CURRENTLY UNKNOWN. CORRECTION/CORRECTIVE ACTION IS ONGOING. (B)(4). MDRS ASSOCIATED WITH THIS EVENT: 2122870-2012-01600, 2122870-2012-01607, 2122870-2012-01608, 2122870-2012-01609.