MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-26 for VITROS 5600 INTEGRATED SYSTEM 6802413 manufactured by Ortho-clinical Diagnostics.
[89468808]
The investigation determined that lower than expected quality control results were obtained on vitros myog reagent using non-vitros biorad quality control material on a vitros 5600 integrated system. It was concluded that the qc shift low was caused by an instrument issue as the same non-vitros biorad qc fluids were run on the customer? S other analyzer without experiencing the same shift. A review of the historical qc results indicates qc performance was acceptable up until the day of the event. An ortho fe performed service actions including replacement of the reagent metering probe, inspections of the microwell incubator, and verification of adjustments to well wash, signal reagent, micro-immunoassay metering and luminometer subsystems. Acceptable myog qc performance has been maintained following service actions.
Patient Sequence No: 1, Text Type: N, H10
[89468809]
The customer observed lower than expected quality control results on vitros myog reagent using non-vitros biorad quality control material on a vitros 5600 integrated system. (b)(6). The customer discontinued patient sample testing because quality control was unacceptable. However, the investigation cannot conclude that patient sample results would not be affected if the event were to recur undetected. There was no allegation of harm. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319681-2017-00084 |
| MDR Report Key | 6894861 |
| Date Received | 2017-09-26 |
| Date of Report | 2017-09-26 |
| Date of Event | 2017-08-17 |
| Date Mfgr Received | 2017-08-29 |
| Device Manufacturer Date | 2013-03-14 |
| Date Added to Maude | 2017-09-26 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| 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 | DDR |
| Date Received | 2017-09-26 |
| 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 |
| Brand Name | VITROS 5600 INTEGRATED SYSTEM |
| Generic Name | CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-09-26 |
| Catalog Number | 6802413 |
| 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 | 2017-09-26 |