FDA.reportPublic FDA data

MAUDE MDR 7037790

MDR report key
7037790
Report number
1823260-2017-02634
Event key
0
Event type
3
Date of event
2017-10-26
Date received
2017-11-16
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 8000 E 602 MODULEIMMUNOCHEMISTRY ANALYZERROCHE DIAGNOSTICSLTJE602ASKUNAR Y
1COBAS 8000 E 602 MODULEIMMUNOCHEMISTRY ANALYZERROCHE DIAGNOSTICSJJEE602ASKUNAR Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-11-160

Event Narratives#

N

Patient 1

THIS EVENT OCCURRED IN (B)(6).

D

Patient 1

THE CUSTOMER COMPLAINED OF ERRONEOUS RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS FREE PSA IMMUNOASSAY (FREE PSA) ON 3 COBAS 8000 E 602 MODULES. RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. IT IS NOT KNOWN WHICH RESULTS WERE BELIEVED TO BE CORRECT. THIS MEDWATCH WILL COVER E602 MODULE SERIAL (B)(4). THE INITIAL FREE PSA RESULT ON E602 MODULE WITH SERIAL NUMBER (B)(4) WAS 0.011 NG/ML. THE SAMPLE WAS REPEATED ON E602 MODULE SERIAL NUMBER (B)(4) AND THE RESULT WAS 0.671 NG/ML. THE SAMPLE WAS REPEATED ON E602 MODULE SERIAL NUMBER (B)(4) AND THE RESULT WAS 0.787 NG/ML. BASED ON THE DATA PROVIDED, THERE IS AN ADDITIONAL PATIENT SAMPLE WITH ERRONEOUS FREE PSA RESULTS. IT IS NOT CLEAR WHETHER THIS ADDITIONAL SAMPLE IS FROM THE 1 PATIENT THE CUSTOMER COMPLAINED ABOUT OR IF THIS IS FOR A DIFFERENT PATIENT. IT IS ALSO NOT KNOWN WHICH E602 MODULE PRODUCED THE RESULTS. CLARIFICATION ON THIS HAS BEEN REQUESTED BUT HAS NOT BEEN PROVIDED. THE INITIAL FREE PSA RESULT WAS 0.01 NG/ML. THE REPEAT RESULT WAS 0.395 NG/ML. IT IS NOT KNOWN WHICH RESULT IS BELIEVED TO BE CORRECT. THIS INFORMATION WAS REQUESTED BUT HAS NOT BEEN PROVIDED. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE FREE PSA REAGENT LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED. A SPECIFIC ROOT CAUSE WAS NOT IDENTIFIED. ADDITIONAL INFORMATION WAS REQUESTED FOR INVESTIGATION BUT WAS NOT PROVIDED. THE CUSTOMER HAS NOT PROVIDED ANY ADDITIONAL INFORMATION RELATED TO THIS EVENT, THEREFORE THE INVESTIGATION COULD NOT BE COMPLETED. A GENERAL PRODUCT PROBLEM IS EXCLUDED.