FDA.reportPublic FDA data

MAUDE MDR 1931053

MDR report key
1931053
Report number
1823260-2010-07535
Event key
0
Event type
3
Date of event
2010-11-05
Date received
2010-12-17
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 ERIC KOLODZIEJ
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
1COBAS 6000 E601 MODULEIMMUNOCHEMISTRY ANALYZERROCHE DIAGNOSTICSGMNNA04745922001NAR Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12010-12-170

Event Narratives#

N

Patient 1

INVESTIGATION OF THE PATIENT SAMPLE VERIFIED THE POSITIVE ELECSYS TOXOPLASMA IGG RESULTS. THE POSITIVE RESULTS WAS FURTHER CONFIRMED BY NEUTRALIZATION ASSAY AS WELL AS COMPETITOR ASSAYS, BOUTY BEIA TOXOPLASMA IGG ASSAYS (QUANT AND AVIDITY). THE ELCSYS TOXOPLASMA IGG RESULTS ARE REGARDED AS CORRECTLY REACTIVE. NO ADVERSE EVENTS WERE REPORTED.

D

Patient 1

THE CUSTOMER RECEIVED QUESTIONABLE TOXOPLASMA IGG (IGG ANTIBODIES TO TOXOPLASMA GONDII) FOR ONE PATIENT SAMPLE. THE INITIAL TOXOPLASMA IGG RESULT WAS 121.4 IU/ML. THE PHYSICIAN ORDERED ADDITIONAL TESTING BE PERFORMED. THE SAMPLE WAS REPEATED USING AN UNKNOWN COMPETITOR ASSAY, IT GENERATED A NEGATIVE RESULT. AVIDITY TESTING PERFORMED ON THE SAMPLE WAS ALSO NEGATIVE. THE PATIENT'S TOXOPLASMA IGM RESULTS HAVE ALWAYS BEEN NEGATIVE. ALL RESULTS WERE REPORTED OUTSIDE THE LABORATORY AND TO THE PHYSICIAN. THE PATIENT WAS NOT HARMED BY THE EVENT. THE TOXOPLASMA IGG REAGENT LOT NUMBER WAS 00158276.

N

Patient 1

THIS EVENT OCCURRED IN (B)(6).