MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-04-10 for VITROS 5600 INTEGRATED SYSTEM 6802413 manufactured by Ortho-clinical Diagnostics.
[2591494]
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).
Patient Sequence No: 1, Text Type: D, B5
[9952930]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319681-2012-00061 |
| MDR Report Key | 2525257 |
| Report Source | 05 |
| Date Received | 2012-04-10 |
| Date of Report | 2012-04-10 |
| Date of Event | 2012-02-06 |
| Date Mfgr Received | 2012-03-02 |
| Device Manufacturer Date | 2010-05-24 |
| Date Added to Maude | 2012-04-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. JOSEPH FALVO |
| Manufacturer Street | 100 INDIGO CREEK DRIVE |
| Manufacturer City | ROCHESTER NY 14626 |
| Manufacturer Country | US |
| Manufacturer Postal | 14626 |
| Manufacturer Phone | 5854533000 |
| Manufacturer G1 | ORTHO-CLINICAL DIAGNOSTICS |
| Manufacturer Street | 100 INDIGO CREEK DRIVE |
| Manufacturer City | ROCHESTER NY 14626 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 14626 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VITROS 5600 INTEGRATED SYSTEM |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | DKH |
| Date Received | 2012-04-10 |
| Catalog Number | 6802413 |
| Operator | OTHER |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORTHO-CLINICAL DIAGNOSTICS |
| Manufacturer Address | 100 INDIGO CREEK DRIVE ROCHESTER NY 14626 US 14626 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-04-10 |