MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-25 for VITROS CHEMISTRY PRODUCTS PHYT SLIDES 8298671 manufactured by Ortho-clinical Diagnostics.
[145001261]
The investigation determined that higher and lower than expected results were obtained from quality control (qc) fluids using vitros chemistry products phenytoin (phyt) slides in combination with a vitros 5600 integrated system. There were two events discovered during the investigation. Event #1: (b)(6) 2019- gen 17: biorad l3, lot: 40983: results of 28. 0 and 29. 13 ug/ml versus an expected result of 22. 63 ug/ml. The most likely cause of this event was a suboptimal calibration as acceptable performance was attained following a second calibration event. Event #2: (b)(6) 2019- gen 17: biorad l3, lot: 40983: results of 9. 31, 14. 40, 8. 62 and 29. 55 ug/ml versus an expected result of 22. 63 ug/ml ortho pv1, lot: w5903: result of 10. 74 ug/ml versus an expected result of 13. 5 ug/ml. Gen 18: biorad l3, lot: 40983: results of 32. 05, 32. 35 and 30. 40 ug/ml versus an expected result of 22. 63 ug/ml. Ortho pv1, lot: w5903: result of 17. 20 ug/ml versus an expected result of 13. 6 ug/ml. Ortho pv2, lot: x5905: results of 26. 80 and 32. 54 ug/ml versus an expected result of 22. 3 ug/ml. The definitive assignable cause of event #2 was likely instrument related. The results of pre-service within-run vitros phyt precision testing were not within acceptable guidelines, indicating the vitros 5600 integrated system was not performing as intended when processing vitros phyt slides. After a field engineer completed service actions which included adjustments to the alignment of the immunorate wash and insert depth, cleaning the microslide incubator and then calibrating the instrument, acceptable within-run precision vitros phyt results were attained. In addition, the customer is not following proper protocol for immunowash fluid (iwf) handling. Therefore, an issue with the iwf cannot be ruled out as a contributor of the events. Historical qc results were inconsistent for vitros phyt, however, they stabilized following service actions on the instrument indicating that an issue with either reagent lot associated with event #2 is not a likely contributor to the events. Furthermore, continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros phyt reagent lots: 2617-0168-4311 or 2618-0169-6411.
Patient Sequence No: 1, Text Type: N, H10
[145001262]
A customer reported imprecise results obtained from vitros chemistry products performance verifiers (pv) and a non-vitros biorad quality control (qc) fluid using vitros chemistry products phenytoin (phyt) slides in combination with a vitros 5600 integrated system. Vitros phyt results from gen 17: biorad l3, lot: 40983: results of 28. 0 and 29. 13 ug/ml versus an expected result of 22. 63 ug/ml. Vitros phyt results from gen 17: biorad l3, lot: 40983: results of 9. 31, 14. 40, 8. 62 and 29. 55 ug/ml versus an expected result of 22. 63 ug/ml. Ortho pv1, lot: w5903: result of 10. 74 ug/ml versus an expected result of 13. 5 ug/ml. Vitros phyt results from gen 18: biorad l3, lot: 40983: results of 32. 05, 32. 35 and 30. 40 ug/ml versus an expected result of 22. 63 ug/ml. Ortho pv1, lot :w5903 result of 17. 20 ug/ml versus an expected result of 13. 6 ug/ml. Ortho pv2, lot: x5905 results of 26. 80 and 32. 54 ug/ml versus an expected result of 22. 3 ug/ml. Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples. The imprecise results were attained from qc fluids. However, it cannot be concluded that patient sample results were not affected and would not be affected if the event were to recur undetected. There has been no allegation of any patient harm as a result of this event. This report is number 2 of 3 mdr? S for this event. Three (3) 3500a forms are being submitted for this event as 3 devices were involved. This report corresponds to ortho clinical diagnostics inc. Complaint number: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319809-2019-00016 |
| MDR Report Key | 8449812 |
| Date Received | 2019-03-25 |
| Date of Report | 2019-03-25 |
| Date of Event | 2019-01-23 |
| Date Mfgr Received | 2019-02-26 |
| Device Manufacturer Date | 2018-10-30 |
| Date Added to Maude | 2019-03-25 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JAMES A STEVENS |
| 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 | 513 TECHNOLOGY BLVD. |
| Manufacturer City | ROCHESTER NY 14652 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 14652 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VITROS CHEMISTRY PRODUCTS PHYT SLIDES |
| Generic Name | IN VITRO DIAGNOSTCS |
| Product Code | DIP |
| Date Received | 2019-03-25 |
| Catalog Number | 8298671 |
| Lot Number | 2617-0168-4311 |
| Device Expiration Date | 2019-03-15 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2019-03-25 |