FDA.reportPublic FDA data

MAUDE MDR 8064759

MDR report key
8064759
Report number
1823260-2018-04224
Event key
0
Event type
3
Date of event
2018-10-25
Date received
2018-11-13
Adverse event
3
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
1ELECSYS RUBELLA IGG IMMUNOASSAYENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLAROCHE DIAGNOSTICSLFXNA04618793190ASKUR Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-11-130

Event Narratives#

N

Patient 1

THIS EVENT OCCURRED IN (B)(6).

D

Patient 1

THE CUSTOMER STATED THAT THEY RECEIVED QUESTIONABLE RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS RUBELLA IGG IMMUNOASSAY AND THE ELECSYS RUBELLA IGM IMMUNOASSAY ON A COBAS 6000 E 601 MODULE. OF THE TWO TESTS, THE SAMPLE HAD AN ERRONEOUS RUBELLA IGG VALUE THAT WAS REPORTED OUTSIDE OF THE LABORATORY TO MEDICAL PERSONNEL TREATING THE PATIENT. THE SAMPLE RESULTED WITH A POSITIVE RUBELLA IGG VALUE WHEN TESTED ON THE E 601 ANALYZER. THE SAMPLE WAS SENT TO A REFERENCE LABORATORY WHERE IT WAS TESTED USING AN UNKNOWN METHOD, RESULTING IN A NEGATIVE VALUE. THE PATIENT RETURNED TO THE CUSTOMER SITE AND HAD ANOTHER SAMPLE TESTED. THIS SAMPLE ALSO HAD A POSITIVE RUBELLA IGG VALUE WHEN TESTED ON THE E 601. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. THE E 601 ANALYZER SERIAL NUMBER IS (B)(4).