FDA.reportPublic FDA data

MAUDE MDR 2000994

MDR report key
2000994
Report number
2243471-2011-00009
Event key
0
Event type
3
Date of event
2011-02-14
Date received
2011-02-24
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
0
Event location
0

Manufacturer Contact#

Contact
VINCENT STAGNITTO
Address
1080 US HWY 202S BRANCHBURG NJ 08876 US
Phone
908-908-9082
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1COBAS? TAQMAN? 48 ANALYZERANALYZER, CHEMISTRY, MICRO, FOR CLINICAL USE, PRODUCT CODE: JJFROCHE DIAGNOSTICS, LTD.JJFY N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-02-240

Event Narratives#

D

Patient 1

A CUSTOMER SITE IN (B)(6) REPORTED THAT THEY RECEIVED AN ERRONEOUS UNDER-QUANTIFIED RESULT WHEN USING THE COBAS TAQMAN (B)(6) TEST FOR USE WITH THE HIGH PURE SYSTEM TEST - (B)(6). THEIR INITIAL RESULT WAS TARGET NOT DETECTED (TND) BUT THE CUSTOMER RECOGNIZED THAT THE NORMALIZED AND UN-NORMALIZED ANALYSIS CURVES WERE DIFFERENT AND INDICATED THAT THE SAMPLE WAS A HIGH TITER SAMPLE. WHEN THE SAMPLE WAS RE-TESTED, IT GENERATED A VERY HIGH TITER RESULT - (B)(6).

N

Patient 1

THIS ISSUE IS CURRENTLY UNDER INVESTIGATION. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. (B)(4).

N

Patient 1

(B)(4) COMPUTER SOFTWARE PERFORMANCE TESTS CONDUCTED, ALGORITHM ANALYSIS, SOFTWARE / FIRMWARE CAUSED EVENT, UNUSUAL EVENT. THE INVESTIGATION DETERMINED THAT THE DISCREPANT TARGET NOT DETECTED (TND) RESULT WAS CAUSED BY THE BASELINE NORMALIZATION CALCULATION OF THE ELTH ALGORITHM. IN VERY RARE INSTANCES, THE ANALYSIS CURVES OF THE AFFECTED SAMPLES ARE NOISY IN THE FIRST FEW CYCLES. THE (B)(4) CURVES DID NOT HAVE ENOUGH VALID BASELINE POINTS FOR A CORRECT CALCULATION OF THE BASELINE. THEREFORE, THE DATA POINTS OF THE PLATEAU REGION WERE INCORRECTLY USED FOR THE CALCULATION OF THE BASELINE, LEADING TO AN INCORRECT TND RESULT. ALL AFFECTED ROCHE MOLECULAR SYSTEMS ASSAYS WERE ASSESSED FOR RISKS AND POSSIBLE IMPACTS DUE TO THE ELTH BASELINE NORMALIZATION ANOMALY. ALL POTENTIAL FAILURE MODES WERE ANALYZED. THE ANOMALY HAS AN EXTREMELY LOW RATE OF OCCURRENCE. (B)(4). ALL RESIDUAL RISKS IDENTIFIED WERE DETERMINED TO BE IN THE ACCEPTABLE OR ALARP (AS LOW AS REASONABLY PRACTICAL) RANGE. THE OVERALL RESIDUAL RISK WAS DETERMINED TO BE ACCEPTABLE WITH NO MAJOR IMPACT ON ASSAY OR SYSTEM PERFORMANCE EXPECTED. (B)(4).