FDA.reportPublic FDA data

MAUDE MDR 1369584

MDR report key
1369584
Report number
2122870-2009-00035
Event key
0
Event type
3
Date of event
2009-01-09
Date received
2009-01-30
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
NORA ZEROUNIAN, GROUP MGR
Address
200 S. KRAEMER BLVD. PO BOX 8000, MAIL STOP: W-110 BREA CA 92822 US
Phone
714-714-7149
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ACCESS 2 IMMUNOASSAY SYSTEMDISCRETE PHOTOMETRIC CHEMISTRY ANALYZERBECKMAN COULTER, INC.NDRACCESS 2 IMMUNOASSAY SYSTEM81600NNAN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12009-01-300

Event Narratives#

D

Patient 1

A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING A LOWER THAN EXPECTED RESULT FOR INHIBIN A THAT WAS GENERATED BY THE ACCESS 2 INSTRUMENT FOR ONE PT. THE INITIAL INHIBIN A RESULT WAS 25.0PG/ML. THE RESULT WAS NOT REPORTED OUT OF THE LAB. THE ORIGINAL SAMPLE WAS RE-TESTED TWICE AND RESULTS OF 104.7PG/ML AND 102.3PG/ML WERE OBTAINED, RESPECTIVELY. THE RESULT OF 102.3PG/ML WAS REPORTED OUT OF THE LAB. THERE WAS NO EFFECT TO PT TREATMENT IN CONNECTION WITH THIS EVENT.

N

Patient 1

THE SAMPLE WAS COLLECTED IN A SERUM TUBE AND IT WAS CENTRIFUGED AT 3,500 RPM FOR 10 MINUTES. THIS IS THE ONLY RESULT AND ASSAY IN QUESTION AT THIS TIME. QC WAS RECOVERING WITHIN EXPECTED RANGES PRIOR TO AND ON THE DAY OF EVENT. A SYSTEM CHECK PERFORMED ON 01/12/09 WAS WITHIN THE PUBLISHED SPECIFICATIONS. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED: THE FSE REPLACED THE TRANSDUCER. THE FSE VERIFIED THE REPAIR PER ESTABLISHED PROCEDURES, AND RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS. PER FSE, THE TRANSDUCER VOLTAGE WAS NOT HOLDING AT THE CORRECT READING WHILE SONICATING THE PARTICLES WHILE ASPIRATING. IT WAS INTERMITTENT WHICH COULD EXPLAIN WHY NOT ALL TESTING WAS AFFECTED. ALSO, NOT ALL ASSAYS ARE SENSITIVE TO SONICATING PROBLEMS. THE FSE STATED THIS ISSUE WAS THE ROOT CAUSE FOR THIS EVENT. EVEN THOUGH THE LOW INHIBIN A RESULT OBTAINED IS UNLIKELY TO BE THE BASIS TO INITIATE OR WITHHOLD TREATMENT, IN THIS EVENT THE HARDWARE FAILURE MAY HAVE AFFECTED OTHER PIVOTAL ASSAYS. ERRONEOUS RESULTS OF A PIVOTAL ASSAY MAY CONTRIBUTE TO SERIOUS INJURY TO THE PT. HARDWARE ISSUE ADDRESSED BY THE FSE LIKELY CONTRIBUTED TO THIS EVENT. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT. (B)(4).