FDA.reportPublic FDA data

MAUDE MDR 6882226

MDR report key
6882226
Report number
1823260-2017-02032
Event key
0
Event type
3
Date of event
2017-08-28
Date received
2017-09-21
Adverse event
0
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
NA MICHAEL LESLIE
Address
9115 HAGUE ROAD NA INDIANAPOLIS IN 46250 US
Phone
317-317-3175
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
0COBAS 6000 E 601 MODULEIMMUNOCHEMISTRY ANALYZERROCHE DIAGNOSTICSLTJE601ASKUNAR Y
1COBAS 6000 E 601 MODULEIMMUNOCHEMISTRY ANALYZERROCHE DIAGNOSTICSJJEE601ASKUNAR Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-09-210

Event Narratives#

N

Patient 1

THIS EVENT OCCURRED IN (B)(6). (B)(4).

D

Patient 1

THE CUSTOMER COMPLAINED OF AN ERRONEOUS HIGH RESULT FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS TOTAL PSA IMMUNOASSAY (TOTAL PSA) ON A COBAS 6000 E 601 MODULE. WEEKLY MAINTENANCE WAS PERFORMED ON (B)(6) 2017. QUALITY CONTROLS (QC) WERE HIGH AFTER MAINTENANCE. QC WAS REPEATED AND WAS WITHIN THE EXPECTED TARGET. NO MORE QC WAS RUN FOR THE REMAINDER OF THE DAY. DURING VALIDATION DELTA CHECKS, ERRONEOUS RESULTS WERE IDENTIFIED. THE INITIAL TOTAL PSA RESULT WAS 5.19 NG/ML. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. ON (B)(6) 2017 THE SAMPLE WAS REPEATED AND THE RESULT WAS 0.692 NG/ML. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT BASED ON THE PATIENT?S MEDICAL HISTORY. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE TOTAL PSA REAGENT LOT NUMBER WAS 216023 WITH AN EXPIRATION DATE OF 30-JUN-2018. THE CUSTOMER NOTED THERE WERE A FEW FIBRIN STRANDS VISIBLE IN THE ORIGINAL SAMPLE. THE CUSTOMER COMPLAINED OF QC ISSUES WITH OTHER ASSAYS AS WELL. CALIBRATION SIGNALS WERE FOUND TO BE SLIGHTLY LOW HOWEVER; THERE IS NO INDICATION OF A REAGENT ISSUE. A SPECIFIC ROOT CAUSE WAS NOT IDENTIFIED. ADDITIONAL INFORMATION WAS REQUESTED FOR INVESTIGATION BUT WAS NOT PROVIDED. POSSIBLE ROOT CAUSES MAY BE RELATED TO PREANALYTIC ISSUES SUCH AS CLOTTING TIME OR VISIBLE FIBRIN STRANDS. ADDITIONAL POSSIBLE ROOT CAUSES FOR THIS EVENT MAY BE INSUFFICIENT ELECTROMAGNETIC INTERFERENCE LAB COMPLIANCE, SAMPLE QUALITY, INSUFFICIENT MAINTENANCE, OR CONTAMINATION OF THE ENVIRONMENT WITH THE ANALYTE.