MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-15 for VITROS 5600 INTEGRATED SYSTEM 6802413 manufactured by Ortho-clinical Diagnostics.
[93327964]
The investigation determined lower than expected vitros dgxn results were obtained from a single level of vitros tdm performance verifier (lot t5896) quality control fluid processed on a vitros 5600 integrated system. A vitros dgxn slide lot issue was ruled out as a contributing factor as acceptable performance was observed using the same dgxn slide lot on an alternate vitros instrument in the customer's laboratory. The investigation determined the most likely assignable cause to be an analyzer issue. Vitros dgxn precision testing performed using two different slide lots was not within acceptable guidelines, indicating an instrument issue was likely the contributing factor of the lower than expected dgxn results. An ortho field engineer is expected to go on site to investigate the vitros analyzer and resolve the issue. The investigation is ongoing.
Patient Sequence No: 1, Text Type: N, H10
[93327965]
A customer obtained lower than expected vitros dgxn results from a single level of vitros tdm performance verifier (lot t5896) quality control fluid (tdm = 1. 7, 1. 9, 1. 9, 2. 0 versus expected 2. 7 ng/ml) processed on a vitros 5600 integrated system. Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples. The unexpected vitros dgxn results were generated from a non-patient fluid, 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 the event. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319681-2017-00111 |
| MDR Report Key | 7034646 |
| Date Received | 2017-11-15 |
| Date of Report | 2017-11-15 |
| Date of Event | 2017-10-18 |
| Date Mfgr Received | 2017-10-18 |
| Device Manufacturer Date | 2016-08-04 |
| Date Added to Maude | 2017-11-15 |
| 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 | 2017-11-15 |
| 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 | 2017-11-15 |