FDA.reportPublic FDA data

MAUDE MDR 8518095

MDR report key
8518095
Report number
1823260-2019-01492
Event key
0
Event type
3
Date of event
2019-03-31
Date received
2019-04-16
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
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
1ELECSYS VITAMIN D TOTAL IIVITAMIN D TEST SYSTEMROCHE DIAGNOSTICSMRGNA0746421519036669600R Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-04-160

Event Narratives#

N

Patient 1

THIS EVENT OCCURRED IN (B)(6).

D

Patient 1

THE INITIAL REPORTER COMPLAINED OF AN ERRONEOUS HIGH RESULT FOR 1 PATIENT TESTED FOR ELECSYS VITAMIN D TOTAL II (VITAMIN D II) ON A COBAS 6000 E 601 MODULE. THE INITIAL RESULT WAS 60.94 NG/ML. THE REPEAT RESULT WAS 24.07 NG/ML. THE ERRONEOUS RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE E601 MODULE SERIAL NUMBER WAS (B)(4). THE CUSTOMER USED A CENTRIFUGATION TIME OF 5 MINUTES FOR THE SAMPLE TUBE INSTEAD OF 10 MINUTES AS RECOMMENDED BY THE TUBE MANUFACTURER. ROCHE DIAGNOSTICS HAS ISSUED AN URGENT MEDICAL DEVICE CORRECTION FOR THIS ISSUE, ENTITLED "ELECSYS? VITAMIN D TOTAL II ASSAY ? NON-REPRODUCIBLE FALSE HIGH RESULTS." THIS CORRECTION HAS BEEN REPORTED TO FDA. DURING THE IMPLEMENTATION OF THE ELECSYS VITAMIN D TOTAL II ASSAY ON THE MODULAR ANALYTICS E 170 MODULE, AND COBAS E 601 AND 602 SYSTEMS, THERE WERE REPORTS OF NON-REPRODUCIBLE, FALSE HIGH RESULTS. THESE CUSTOMER OBSERVATIONS WERE MADE IN COMPARISONS OF DUPLICATE MEASUREMENTS DURING ASSAY VALIDATION OF ELECSYS VITAMIN D TOTAL II ASSAY OR IN METHOD COMPARISONS WITH ELECSYS VITAMIN D ASSAY (I.E., DURING CONVERSIONS), WHERE THE FALSELY ELEVATED DISCREPANT VALUE DID NOT FIT THE EXPECTED RESULT. THE OBSERVED ELEVATED RESULTS REPORTED WITH THE ELECSYS VITAMIN D II ASSAY WERE NOT CONFIRMED UPON REPEAT TESTING OF THE AFFECTED SAMPLES. THE OBSERVED FINDINGS: THE FIRST RESULT IS ELEVATED, EITHER ABOVE THE UPPER END OF THE MEASURING RANGE (>100 NG/ML OR >250 NMOL/ML), OR WITHIN THE MEASURING RANGE; REPEATED RESULTS ARE SIGNIFICANTLY LOWER. RARE CASES HAVE BEEN REPORTED ON THE COBAS E 411 ANALYZER AND THE COBAS E 801 MODULE. ROCHE IS CONDUCTING INVESTIGATIONS INTO THE REPORTED ISSUE AND HAS DETERMINED THAT THE ELECSYS? VITAMIN D TOTAL II ASSAY IS STRONGLY AFFECTED BY PRE-ANALYTICAL ERRORS. THE INVESTIGATIONS HAVE REPRODUCED THESE FINDINGS WHEN REQUIREMENTS FOR PRE-ANALYTICAL SAMPLE HANDLING HAVE NOT BEEN MET FOR PLASMA SAMPLES. FURTHER INVESTIGATIONS INTO THE REPORTED ISSUE ARE ONGOING. AS A RESULT, THE PRE-ANALYTICAL SAMPLE QUALITY AND COMPLIANCE TO THE TUBE MANUFACTURER?S SPECIFICATIONS IS VERY IMPORTANT TO ASSURE A HIGH QUALITY SAMPLE IN ORDER TO MINIMIZE THE RISK OF OCCURRENCE. INVESTIGATIONS ARE ONGOING TO DETERMINE THE ROOT CAUSE OF THIS ISSUE. A WORKAROUND HAS BEEN PROVIDED TO CUSTOMERS.