N
Patient 1
MAUDE MDR 8350585
- MDR report key
- 8350585
- Report number
- 1823260-2019-00682
- Event key
- 0
- Event type
- 3
- Date of event
- 2019-02-04
- Date received
- 2019-02-19
- 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 | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ELECSYS VITAMIN D TOTAL II | VITAMIN D TEST SYSTEM | ROCHE DIAGNOSTICS | MRG | NA | 07464215160 | 340144 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-02-19 | 0 |
Event Narratives#
D
Patient 1
THE CUSTOMER RECEIVED QUESTIONABLE ELECSYS VITAMIN D G2 ASSAY RESULTS FOR ONE PATIENT FROM COBAS 6000 E 601 MODULE SERIAL NUMBER (B)(4). THE INITIAL RESULT WAS > 100 NG/ML WITH A DATA FLAG. THE CUSTOMER REPEATED THE SAME SAMPLE AND THE RESULT WAS 60.77 NG/ML WHICH WAS REPORTED OUTSIDE OF THE LABORATORY. THE DOCTOR QUESTIONED THE RESULT AS THE PATIENT HAD A RESULT FROM (B)(6) 2018 OF 36.4 NG/ML. ON (B)(6) 2019, THE CUSTOMER REPEATED THE SAME SAMPLE AND THE RESULTS WERE 38.74 NG/ML AND 37.63 NG/ML. THESE RESULTS WERE BELIEVED TO BE CORRECT. THERE WAS NO ADVERSE EVENT. 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.