FDA.reportPublic FDA data

MAUDE MDR 6817765

MDR report key
6817765
Report number
1823260-2017-01811
Event key
0
Event type
3
Date of event
2017-07-01
Date received
2017-08-24
Adverse event
0
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
0COBAS 8000 C 702 MODULECLINICAL CHEMISTRY ANALYZERROCHE DIAGNOSTICSCITC702ASKUNAR Y
1COBAS 8000 C 702 MODULECLINICAL CHEMISTRY ANALYZERROCHE DIAGNOSTICSJJEC702ASKUNAR Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-08-240

Event Narratives#

N

Patient 1

THIS EVENT OCCURRED IN (B)(6). UNIQUE IDENTIFIER (UDI)#: (B)(4).

D

Patient 1

THE CUSTOMER COMPLAINED OF ERRONEOUS RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ALT ALANINE AMINOTRANSFERASE ACC. TO IFCC WITHOUT PYRIDOXAL PHOSPHATE ACTIVATION (ALT) AND AST ASPARTATE AMINOTRANSFERASE ACC. TO IFCC WITHOUT PYRIDOXAL PHOSPHATE ACTIVATION(AST) ON TWO COBAS 8000 C 702 MODULES. ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THIS MEDWATCH WILL COVER C702 MODULE WITH SERIAL NUMBER (B)(4) (C702 MODULE A). REFER TO MEDWATCH WITH (B)(6) FOR INFORMATION ON THE C702 MODULE WITH SERIAL NUMBER (B)(4) (C702 MODULE B) ERRONEOUS RESULTS. ON (B)(6) 2017 THE PATIENT WAS INITIALLY TESTED ON C702 MODULE B AND THE AST RESULT WAS 518.6 U/L. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. ON (B)(6) 2017 THE DOCTOR ASKED FOR THE SAMPLE TO BE REPEATED. THE SAMPLE WAS REPEATED ON C702 MODULE A AND THE AST RESULT WAS 566.6 U/L. THE SAMPLE WAS THEN REPEATED ON C702 MODULE B AND THE AST RESULT WAS 4467.8 U/L. THE SAMPLE WAS REPEATED IN DECREASE MODE AND THE AST RESULT FROM C702 MODULE A WAS 292.9 U/L. ON (B)(6) 2017 THE PATIENT WAS INITIALLY TESTED ON C702 MODULE B AND THE ALT RESULT WAS 232.9 U/L. THE SAMPLE WAS REPEATED ON C702 MODULE B AND THE ALT RESULT WAS 5917.3 U/L. THE SAMPLE WAS REPEATED IN DECREASE MODE AND THE ALT RESULT FROM C702 MODULE B WAS 5902.3 U/L. THE AST RESULT OF 292.9 U/L AND THE ALT RESULT OF 5902.3 U/L WERE REPORTED OUTSIDE OF THE LABORATORY WHERE THE PATIENT (WHO HAPPENS TO BE A DOCTOR) QUESTIONED THE LOW AST RESULT. THE AST RESULT OF 4467.8 U/L WAS BELIEVED TO BE CORRECT. TWO NEW SAMPLES WERE OBTAINED ON (B)(6) 2017 AND THE AST RESULTS WERE BOTH > 4000 U/L. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE LAST MONTHLY MAINTENANCE PRIOR TO THE EVENT WAS PERFORMED ON (B)(6) 2017 WHERE CUVETTES AND THE PHOTOMETER WERE REPLACED. CALIBRATION AND QUALITY CONTROLS WERE ACCEPTABLE. A SPECIFIC ROOT CAUSE WAS NOT IDENTIFIED. ADDITIONAL INFORMATION WAS REQUESTED FOR INVESTIGATION BUT WAS NOT PROVIDED. SINCE CALIBRATION AND QC WERE ACCEPTABLE, BOTH AN INSTRUMENT AND REAGENT PROBLEM CAN BE EXCLUDED AS A ROOT CAUSE. THE CUSTOMER HAS NOT COMPLAINED OF ANY ADDITIONAL ISSUES.