FDA.reportPublic FDA data

MAUDE MDR 7086080

MDR report key
7086080
Report number
1823260-2017-02851
Event key
0
Event type
3
Date of event
2017-11-15
Date received
2017-12-06
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
1IGM ANTIBODIES TO CYTOMEGALOVIRUS (CMV IGM)ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUSROCHE DIAGNOSTICSLFZNA04784618190176724R Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-12-060

Event Narratives#

N

Patient 1

(B)(4). (B)(6).

D

Patient 1

THE CUSTOMER RECEIVED A (B)(6) ELECSYS CMV IGM IMMUNOASSAY RESULT FOR ONE PATIENT SAMPLE. THE RESULT FROM A COBAS 6000 E 601 MODULE WAS (B)(6). NO SPECIFIC RESULT WAS PROVIDED. THE RESULT WAS REPORTED TO THE PATIENT'S PHYSICIAN, BUT AS IT WAS DISCREPANT FROM THE PREVIOUS RESULT FOR THE PATIENT THE SAMPLE WAS REPEATED. THE SAMPLE WAS REPEATED AND THE RESULT FROM VIDAS, LIASON XL, AND ANOTHER UNKNOWN ANALYZER WERE ALL (B)(6). NO SPECIFIC RESULTS WERE PROVIDED. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE PATIENT'S DIAGNOSIS WAS NOT AFFECTED. THE ANALYZER SERIAL NUMBER WAS REQUESTED BUT WAS NOT PROVIDED.