MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-05 for VITROS 5600 INTEGRATED SYSTEM 6802413 manufactured by Ortho-clinical Diagnostics.
[85950236]
The investigation determined that 2 lower than expected vitros amon results were obtained from a quality control fluid using vitros amon slide lot 1017-0245-8848 tested on a vitros 5600 integrated system (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 amon 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 evaporation caps and the collection assembly and mirror/illuminator lens kit, acceptable vitros amon precision results were obtained, indicating service actions had returned the vitros 5600 system to expected performance. As the reagent lot was changed after service actions were complete, vitros amon slide lot 1017-0245-8848 cannot be completely ruled out as a contributing factor.
Patient Sequence No: 1, Text Type: N, H10
[85950237]
A customer reported imprecise quality control results (qc) using vitros clinical chemistry products ammonia (amon) slides on a vitros 5600 integrated system. Vitros liquid performance (lot a5363) results of 148. 1 and 135. 7 umol/l compared to an expected result of 192. 3 umol/l. Biased results of the magnitude and direction observed may lead to inappropriate physician action if patient samples were affected. Although there were no reports of affected patient sample results, it cannot be confirmed that patient sample results were not affected or 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 | 1319681-2017-00072 |
| MDR Report Key | 6841639 |
| Date Received | 2017-09-05 |
| Date of Report | 2017-09-05 |
| Date of Event | 2017-08-01 |
| Date Mfgr Received | 2017-08-08 |
| Device Manufacturer Date | 2012-08-10 |
| Date Added to Maude | 2017-09-05 |
| 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 | 2017-09-05 |
| 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 | 2017-09-05 |
| 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 | 2017-09-05 |