FDA.reportPublic FDA data

MAUDE MDR 5134659

MDR report key
5134659
Report number
1823260-2015-04291
Event key
0
Event type
3
Date of event
2015-08-01
Date received
2015-10-08
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 DIAGNOSTICSJHRNA11930419122181429R Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-10-080

Event Narratives#

N

Patient 1

THIS EVENT OCCURRED IN (B)(6).

D

Patient 1

THE CUSTOMER RECEIVED QUESTIONABLE IMMUNOGLOBULIN E (IGE) RESULTS FOR ONE PATIENT FROM AN UNKNOWN ROCHE ANALYZER. THE INITIAL RESULT WAS FLAGGED AS GREATER THAN THE TEST RANGE AND THE SAMPLE WAS REANALYZED WITH A 1:20 DILUTION. THE RESULT THAT WAS RELEASED WAS 44,000 IU/ML. TWO WEEKS LATER ON AN UNSPECIFIED DATE, THE PATIENT HAD IGE TESTED AT ANOTHER HOSPITAL USING THE BECKMAN COULTER IMAGE AND THE RESULT WAS 125 IU/ML. THE PATIENT'S DOCTOR ASKED WHY THE INITIAL RESULT DID NOT CORRELATED WITH WHAT THE OTHER HOSPITAL RELEASED. ON (B)(6) 2015, THE PATIENT WAS RETESTED AND THE RESULT WAS 2500 IU/ML FLAGGED AS GREATER THAN TEST RANGE. WHEN TESTED WITH A 1:20 DILUTION, THE RESULT WAS 50,000 FLAGGED AS GREATER THAN TEST RANGE. ON (B)(6) 2015, THE PATHOLOGIST DECIDED TO CHECK SERUM PROTEIN ELECTROPHORESIS AND THE GAMMA LEVELS WERE NORMAL. SHE EXPECTED THEM TO BE ELEVATED DUE TO HIGH IGE LEVELS. THE PATHOLOGIST BELIEVED THE RESULTS WERE NOT CORRECT. ON (B)(6) 2015, A SAMPLE FROM THE PATIENT WAS TESTED AT ANOTHER SITE USING A COBAS E601 ANALYZER AND THE RESULT WAS 2500 IU/ML FLAGGED AS GREATER THAN THE TEST RANGE. WHEN DILUTED 1:20, THE RESULT WAS 49448 IU/ML. NO ADVERSE EVENT ADVERSE EVENT WAS REPORTED.

N

Patient 1

THE ANALYZER INVOLVED WAS A COBAS E601. INFORMATION WAS PROVIDED CONCERNING THE RESULTS: "1ST RUN WITHIN INSTITUTION AROUND 40000 IU/ML (COBAS 6000) 1ST EXTRACTION 2ND RUN DIFFERENT INSTITUTION ROUGHLY 140 IU/ML (BECKMAN COULTER IMMAGE) 2ND EXTRACTION 3RD RUN WITHIN INSTITUTION AROUND 40000 IU/ML (COBAS 6000) 3RD EXTRACTION 4TH RUN DIFFERENT INSTITUTION WITH ROCHE COBAS 6000 SAME SAMPLE AS WITH 3RD EXTRACTION".

N

Patient 1

A SAMPLE FROM THE PATIENT WAS SUBMITTED FOR INVESTIGATION AND THE CUSTOMER'S RESULTS COULD BE REPRODUCED.

N

Patient 1

SAMPLE FROM THE PATIENT WAS SUBMITTED FOR INVESTIGATION AND THE CUSTOMER'S RESULTS WERE CONFIRMED ON A COBAS E601 AND A SIEMENS CENTAUR ANALYZER. BASED ON THESE RESULTS, IT WAS BELIEVED THE RESULT FROM THE BECKMAN COULTER WAS LIKELY INCORRECT. A GENERAL REAGENT ISSUE WITH THE ROCHE IGE ASSAY COULD BE EXCLUDED.