FDA.reportPublic FDA data

MAUDE MDR 5233423

MDR report key
5233423
Report number
1823260-2015-04579
Event key
0
Event type
3
Date of event
2015-10-13
Date received
2015-11-18
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
1IMMUNOGLOBULIN ERADIOIMMUNOASSAY, IMMUNOGLOBULINS (D, E)ROCHE DIAGNOSTICSJHRNA04827031190181429R Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-11-180

Event Narratives#

N

Patient 1

THIS EVENT OCCURRED IN (B)(6).

D

Patient 1

THE CUSTOMER COMPLAINED OF ERRONEOUS RESULTS FOR 1 PATIENT TESTED FOR IMMUNOGLOBULIN E (IGE II). IT IS NOT KNOWN IF ANY ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE INITIAL IGE II RESULT FROM A SERUM SAMPLE WAS 1555 IU/ML. THE SAMPLE WAS REPEATED ON (B)(6) 2015 AND THE RESULT WAS 1487 IU/ML. THE SAMPLE WAS DILUTED X2 AND THE RESULT WAS >5000 IU/ML. THE SAMPLE WAS DILUTED X10 AND THE RESULT WAS 6906 IU/ML. ON (B)(6) 2015, A NEW SAMPLE WAS OBTAINED AND THE RESULT FROM A SERUM SAMPLE WAS 1236 IU/ML. THIS SAMPLE WAS DILUTED X2 AND THE RESULT WAS > 4454 IU/ML. THE SAMPLE WAS DILUTED X10 AND THE RESULT WAS 9154 IU/ML. ON (B)(6) 2015, A NEW SAMPLE WAS OBTAINED AND THE RESULT FROM A SERUM SAMPLE WAS 1115 IU/ML. THE SAMPLE WAS DILUTED X100 AND THE RESULT WAS 13402 IU/ML. THE RESULTS FROM A PLASMA SAMPLE WERE 1192 IU/ML. THE SAMPLE WAS DILUTED X100 AND THE RESULT WAS 13998 IU/ML. IT IS NOT KNOWN IF THE PATIENT WAS ADVERSELY AFFECTED. NO ADVERSE EVENT WAS REPORTED. THE E602 ANALYZER SERIAL NUMBER WAS NOT PROVIDED. THE SAMPLE FROM (B)(6) 2015 WAS SENT IN FOR INVESTIGATION. THE SAMPLE WAS SENT TO AN EXTERNAL LABORATORY AND THE FLUORESCENT ENZYME IMMUNOASSAY (FEIA) IGE RESULT WAS 2803 IU/ML. ON (B)(6) 2015, A SAMPLE FROM A DIFFERENT PATIENT WAS TESTED FOR IGE II AND THE RESULT WAS APPROXIMATELY 2500 IU/ML. THIS PATIENT'S SAMPLE WAS SENT TO THE INVESTIGATION UNIT AS A REFERENCE VALUE. NO FURTHER INFORMATION IS AVAILABLE ABOUT THIS PATIENT. THE SAMPLE WAS SENT TO AN EXTERNAL LABORATORY AND THE FEIA IGE RESULT DILUTED X10 WAS 7004 IU/ML.

N

Patient 1

THE CUSTOMER PROVIDED THE PATIENT SAMPLES IN QUESTION AND THE REFERENCE SAMPLE FOR INVESTIGATION. IT WAS DETERMINED THE PATIENT SAMPLES CONTAIN ANTI-IGE ANTIBODIES THAT AGGREGATE WITH THE IGE MOLECULES. THIS INTERFERENCE IS ADDRESSED IN PRODUCT LABELING.