MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-14 for VITROS 5600 INTEGRATED SYSTEM 6802413 manufactured by Ortho-clinical Diagnostics.
[82938445]
The investigation determined that lower than expected vitros amon results were obtained when testing non-vitros quality controls on a vitros 5600 integrated system. The assignable cause of this event was instrument related. The results of a diagnostic within run vitros amon precision test was not acceptable indicating an instrument related issue. After service actions were completed to clean the evaporation caps and adjusting the slide align guides, the precision was acceptable indicating service actions had returned the analyzer to acceptable performance. The customer continued to obtain unacceptable amon results and an issue was identified involving the slide supply humidity affecting quality control results for multiple assays. After the ortho fe replaced the humidity plate, post-service quality control testing was acceptable indicating the actions have resolved the issue. Since unacceptable performance was observed for multiple reagents including vitros amon and acceptable performance was observed after the service actions using the current reagent lot, vitros amon lot 1017-0245-0578 can be ruled out as a contributing factor.
Patient Sequence No: 1, Text Type: N, H10
[82938446]
The customer observed lower than expected vitros amon results when testing a non-vitros quality control fluid on a vitros 5600 integrated system. Biorad quality control level 3 lot 54193 vitros amon results 139. 1 and 145. 5 umol/l versus expected 259. 99 umol/l. Biased results of the direction and magnitude observed may lead to inappropriate physician action. The vitros amon results were obtained when testing non-vitros quality control samples. 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 | 1319681-2017-00064 |
| MDR Report Key | 6792806 |
| Date Received | 2017-08-14 |
| Date of Report | 2017-08-14 |
| Date of Event | 2017-07-12 |
| Date Mfgr Received | 2017-07-17 |
| Device Manufacturer Date | 2015-09-09 |
| Date Added to Maude | 2017-08-14 |
| 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 | JIF |
| Date Received | 2017-08-14 |
| 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 | 2017-08-14 |
| 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 | 2017-08-14 |