FDA.reportPublic FDA data

MAUDE MDR 2525257

MDR report key
2525257
Report number
1319681-2012-00061
Event key
0
Event type
3
Date of event
2012-02-06
Date received
2012-04-10
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
MR. JOSEPH FALVO
Address
100 INDIGO CREEK DRIVE ROCHESTER NY 14626 US
Phone
585-585-5854
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1VITROS 5600 INTEGRATED SYSTEMCLINICAL CHEMISTRY ANALYZERORTHO-CLINICAL DIAGNOSTICSDKH6802413Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-04-100

Event Narratives#

D

Patient 1

IMPRECISE AND BIASED PHENYTOIN, CARBAMAZEPINE, AND PHENOBARBITAL RESULTS WERE PREDICTED FROM MULTILEVEL NON OCD QUALITY CONTROL FLUIDS USING VITROS PHYT, CRBM AND PHBR SLIDES ON A VITROS 5600 INTEGRATED SYSTEM. VITROS PHYT RESULTS OF 6.762 UG/ML VS. EXPECTED RESULT OF 4.12 UG/ML; 8.008 UG/ML VS. EXPECTED RESULT OF 4.97 UG/ML; 11.925, 13.096, 9.884, AND 3.00 UG/ML VS. EXPECTED RESULT OF 16.63 UG/ML; 12.004, 14.879, 15.907, AND 18.00 UG/ML VS. EXPECTED RESULT OF 25.07 UG/ML; 16.632, 14.907, 16.974, 26.650, 26.242, 16.539, 14.769, 16.630, 15.274, 14.783, 16.906, 27.604, 26.938, 27.641, 27.532, 26.971, 27.191, 28.145, 29.309, 26.477, 27.078, 25.771, 29.392, 15.859, 16.498, 17.020, 17.015, 26.189, 26.395, 15.399, 14.030, 14.950, 15.842, 15.109, 16.743, 16.829, AND 17.072, UG/ML VS. EXPECTED RESULT OF 21.39 UG/ML. VITROS CRBM RESULTS OF 12.984, 12.524 UG/ML VS. EXPECTED OF 9.46 UG/ML; 19.623 UG/ML VS. EXPECTED OF 13.26 UG/ML; 8.905 VS. EXPECTED RESULT OF 13.37 UG/ML. VITROS PHBR RESULTS OF 33.177 AND 56.538 UG/ML VS. EXPECTED RESULT OF 42.10 UG/ML; 57.220 AND 52.669 UG/ML VS. EXPECTED RESULT OF 74.92 UG/ML. NO PATIENT SAMPLE RESULTS WERE KNOWN TO HAVE BEEN AFFECTED. HOWEVER, BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF NOT DETECTED. THERE WAS NO ALLEGATION OF PATIENT HARM. (B)(4).

N

Patient 1

THE INVESTIGATION CONFIRMED THAT MULTIPLE BIASED VITROS PHYT, CRBM AND PHBR RESULTS WERE PREDICTED FROM MULTILEVEL NON OCD QUALITY CONTROL FLUIDS USING THE VITROS 5600 SYSTEM. A DEFINITIVE CAUSE HAS NOT BEEN IDENTIFIED. VITROS SYSTEM MARKER ASSAY WITHIN RUN PRECISION TESTING WAS PERFORMED WHICH DEMONSTRATED THE VITROS 5600 SYSTEM WAS NOT PERFORMING OPTIMALLY. THEREFORE, AN INSTRUMENT ISSUE IS THE MOST LIKELY CONTRIBUTING FACTOR. ADDITIONALLY, OPERATOR PROTOCOL ISSUES INVOLVING FLUID HANDLING CANNOT BE RULED OUT AS CONTRIBUTING FACTORS. THE INVESTIGATION OF THIS EVENT BY OCD TECHNICAL SUPPORT IS ONGOING.