FDA.reportPublic FDA data

MAUDE MDR 6581449

MDR report key
6581449
Report number
1823260-2017-01060
Event key
0
Event type
3
Date of event
2017-05-05
Date received
2017-05-22
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
1COBAS INTEGRA IGA GEN 2IMMUNOGLOBULIN AROCHE DIAGNOSTICSCZPNA03507343190ASKUR Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-05-220

Event Narratives#

N

Patient 1

(B)(4).

D

Patient 1

THE CUSTOMER RECEIVED QUESTIONABLE IGA-2 TINA-QUANT IGA GEN.2 RESULTS FOR EIGHT PATIENT SAMPLES FROM A PACK OF REAGENT THAT HAD JUST A FEW TESTS REMAINING. THE CUSTOMER USED COBAS 8000 C 502 MODULE SERIAL NUMBER (B)(4). THE CUSTOMER REMOVED THE SUSPECT PACK AND LOADED A NEW REAGENT PACK ONTO THE ANALYZER. THEY REPEATED THE SAMPLES ON THE ORIGINAL ANALYZER AND/OR A SECOND COBAS 8000 C 502 MODULE. OF THE DATA PROVIDED FOR SEVEN OF THE PATIENT SAMPLES, ONLY THE RESULTS FOR FIVE PATIENT SAMPLES WERE DISCREPANT. SAMPLE 1 INITIAL RESULT WAS 589 MG/DL AND THE REPEAT RESULT WAS 278 MG/DL. SAMPLE 2 INITIAL RESULT WAS 8 MG/DL WITH A DATA FLAG. THE REPEAT RESULT ON THE ORIGINAL ANALYZER WAS 2924 MG/DL AND THE REPEAT RESULT ON THE SECOND ANALYZER WAS 225 MG/DL. SAMPLE 3 INITIAL RESULT WAS 464 MG/DL AND THE REPEAT RESULT WAS 349 MG/DL. SAMPLE 4 INITIAL RESULT WAS 1165 MG/DL AND THE REPEAT RESULT WAS 283 MG/DL. SAMPLE 5 INITIAL RESULT WAS 1474 MG/DL AND THE REPEAT RESULT WAS 246 MG/DL. THE INITIAL RESULTS WERE REPORTED OUTSIDE THE LABORATORY. AS THE REPEAT RESULT MATCHED BETWEEN THE TWO ANALYZERS, THEY WERE BELIEVED TO BE CORRECT. THE REPEAT RESULTS WERE IMMEDIATELY CALLED TO THE ORDERING PHYSICIANS. THERE WAS NO ADVERSE EVENT. THE FIELD SERVICE REPRESENTATIVE FOUND THERE WAS AN ISSUE WITH THE REAGENT PACK AS IT WAS NEAR THE END OF ITS USEFULNESS. THE REAGENT PACK WAS REPLACED AND SYSTEM INTEGRITY CHECKS, QC, AND PRECISION TESTING WERE PERFORMED.