MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-25 for VITROS 4600 CHEMISTRY SYSTEM 6802445 manufactured by Ortho-clinical Diagnostics.
[88251758]
The investigation determined that higher than expected vitros valp quality control results were obtained from vitros and non-vitros qc fluids run on a vitros 4600 chemistry system. The most likely assignable cause of this event was instrument related. Historical quality control results indicate that within-laboratory quality control precision was unacceptable. An ortho field engineer replaced the photometer lamp and uia metering proboscis, cleaned the photometer filter wheel and lens, fiber optic cable, cuvette incubator and the cuvette transport arm and window and performed all associated adjustments. After the completion of the service actions, one week of vitros valp quality control results was evaluated and verified acceptable within laboratory precision performance. The investigation determined that the likely assignable cause of this event was instrument related.
Patient Sequence No: 1, Text Type: N, H10
[88251759]
A customer observed higher than expected vitros valp quality control results from vitros and non-vitros biorad control fluids processed on the vitros 4600 integrated system. (b)(6). Biased results of the direction and magnitude observed could lead to inappropriate physician action. Ortho was not made aware of any patient sample results being affected. However, the investigation cannot definitively conclude that patient sample results were not affected or would not be affected if the event were to recur undetected. There was no allegation of patient harm as a result of this event. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319681-2017-00081 |
| MDR Report Key | 6889688 |
| Date Received | 2017-09-25 |
| Date of Report | 2017-09-25 |
| Date of Event | 2017-08-29 |
| Date Mfgr Received | 2017-08-29 |
| Device Manufacturer Date | 2012-07-26 |
| Date Added to Maude | 2017-09-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 100 INDIGO CREEK DRIVE |
| Manufacturer City | ROCHESTER NY 14626 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 14626 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VITROS 4600 CHEMISTRY SYSTEM |
| Generic Name | CHEMISTRY ANALYZER |
| Product Code | LEG |
| Date Received | 2017-09-25 |
| Catalog Number | 6802445 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | ORTHO-CLINICAL DIAGNOSTICS |
| Manufacturer Address | 100 INDIGO CREEK DRIVE ROCHESTER NY 14626 US 14626 |
| Brand Name | VITROS 4600 CHEMISTRY SYSTEM |
| Generic Name | CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-09-25 |
| Catalog Number | 6802445 |
| 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 | 2017-09-25 |