MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-29 for VITROS 5600 INTEGRATED SYSTEM 6802413 manufactured by Ortho-clinical Diagnostics.
[89594659]
The investigation confirmed that unexpected vitros amon results were obtained using two levels of non-vitros quality controls and a single level of vitros quality control tested on a vitros 5600 integrated system. The most likely assignable cause of the unexpected vitros amon quality control results is an instrument related issue. The results of amon within-run precision testing demonstrated that the vitros system was not operating as expected. Following service actions that optimized all subsystems of the vitros 5600 integrated system, including the replacement of evaporation caps and wear pads, along with all necessary adjustments, acceptable vitros amon performance was observed.
Patient Sequence No: 1, Text Type: N, H10
[89594660]
The investigation determined unexpected ammonia results were obtained from two levels of a non-vitros biorad quality control fluids and a single level of vitros liquid performance verifier (lpv) when using vitros amon slides on a vitros 5600 integrated system. Br l2 lot 54162 vitros amon result of 105. 0 umol/l versus expected 87. 3 umol/l. Br l3 lot 54163 vitros amon result of 178. 4, 58. 2 and 97. 5 umol/l versus expected 226. 6 umol/l. Lpv l1 lot u4561 vitros amon result of 110. 0 umol/l versus expected 37. 6 umol/l. Biased results of the direction and magnitude observed may lead to inappropriate physician action, should they occur undetected on patient samples. The customer stated that patient samples were not processed during the timeframe the quality control results were outside of established ranges, however the investigation cannot conclude that patient sample results were not affected or would not be affected if the event were to recur undetected. There was no reported allegation of patient harm as a result of this event. This report corresponds to ortho clinical diagnostics inc. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319681-2017-00085 |
| MDR Report Key | 6903893 |
| Date Received | 2017-09-29 |
| Date of Report | 2017-09-29 |
| Date of Event | 2017-09-17 |
| Date Mfgr Received | 2017-09-17 |
| Device Manufacturer Date | 2012-05-22 |
| Date Added to Maude | 2017-09-29 |
| 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 | JIF |
| Date Received | 2017-09-29 |
| 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 | 2017-09-29 |
| 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 | 2017-09-29 |