MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-28 for VITROS 5600 INTEGRATED SYSTEM 6802413 manufactured by Ortho-clinical Diagnostics.
[83984088]
The investigation determined that a lower than expected vitros dgxn quality control result was obtained on a vitros 5600 integrated system. A vitros instrument issue was the most likely assignable cause for the event. An ortho field engineer replaced some of the tubing in the immuno-rate subsystem along with necessary adjustments. Post service, the quality control results were back within expected ranges, indicating the vitros system was returned to its expected performance. Based on the limited number of qc replicates reviewed, an issue with vitros dgxn reagent lot 1913-0242-0362 cannot be completely ruled out as a contributing factor.
Patient Sequence No: 1, Text Type: N, H10
[83984089]
A customer observed a lower than expected vitros dgxn result from a quality control fluid on a vitros 5600 integrated system. Vitros tdm performance verifier level iii (lot l5351) result of 1. 94 ng/ml vs. The expected result of 2. 56 ng/ml no patient samples were in question for vitros dgxn over the time frame of the event. 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 patient harm as a result of this event. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319681-2017-00071 |
| MDR Report Key | 6824109 |
| Date Received | 2017-08-28 |
| Date of Report | 2017-08-28 |
| Date of Event | 2017-07-31 |
| Date Mfgr Received | 2017-07-31 |
| Device Manufacturer Date | 2009-06-26 |
| Date Added to Maude | 2017-08-28 |
| 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 5600 INTEGRATED SYSTEM |
| Generic Name | CHEMISTRY ANALYZER |
| Product Code | KXT |
| Date Received | 2017-08-28 |
| 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 | 2017-08-28 |
| 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 | 2017-08-28 |