MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-01 for VITROS 5600 INTEGRATED SYSTEM 6802413 manufactured by Ortho-clinical Diagnostics.
[91459777]
The investigation determined that a lower than expected vitros dgxn result was obtained from a single level of non-vitros (biorad) quality control fluid using vitros dgxn slide lot 1913-0246-2299, tested on a vitros 5600 integrated system s/n (b)(4). The most likely assignable cause of the lower than expected vitros dgxn quality control result is an instrument performance issue, as a within-run vitros dgxn precision test was outside performance guidelines, indicating that the vitros 5600 integrated system was not performing as intended. Following service actions which included replacement of the motor nut lead screw assembly (z motor) associated with the immuno rate module, acceptable vitros dgxn precision results were obtained, indicating service actions had returned the vitros 5600 system to expected performance. There is no evidence that vitros dgxn slide lot 1913-0246-2299 was not performing as expected. Acceptable performance was observed when processing the quality control fluids after the completion of service actions.
Patient Sequence No: 1, Text Type: N, H10
[91459778]
A customer obtained a lower than expected vitros digoxin (dgxn) quality control result from a non-vitros quality control (qc) fluid, when compared to the customers established mean. The result was generated using vitros chemistry products dgxn slides processed on a vitros 5600 integrated system. Biorad liquichek unassayed chemistry control, lot 31800, vitros dgxn result 1. 96 ng/ml versus dgxn expected result 3. 61 ng/ml biased results of the magnitude and direction observed may lead to inappropriate physician action if patient samples were affected. The customer made no allegations that patient sample results were affected. There was no report of patient harm as a result of this event. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319681-2017-00098 |
| MDR Report Key | 6992804 |
| Date Received | 2017-11-01 |
| Date of Report | 2017-11-01 |
| Date of Event | 2017-09-24 |
| Date Mfgr Received | 2017-10-03 |
| Device Manufacturer Date | 2009-09-28 |
| Date Added to Maude | 2017-11-01 |
| 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 | 0 |
| 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 5600 INTEGRATED SYSTEM |
| Generic Name | CHEMISTRY ANALYZER |
| Product Code | KXT |
| Date Received | 2017-11-01 |
| Catalog Number | 6802413 |
| 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-01 |