MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-08 for VITROS 5600 INTEGRATED SYSTEM 6802413 manufactured by Ortho-clinical Diagnostics.
[40136913]
The investigation determined that a lower than expected ammonia quality control result was obtained from a non-vitros quality control fluid using vitros amon reagent with a vitros 5600 integrated system. The most likely assignable cause of the lower than expected quality control result is instrument related. Vitros amon precision testing performed was outside of ortho guidelines, indicating that the vitros 5600 integrated system was not performing as intended at the time of the events. The cause of the unexpected instrument performance is likely due to microslide incubator contamination. An ortho clinical diagnostics field engineer performed service actions to return the vitros 5600 integrated system to expected performance. Following these service actions, acceptable vitros amon performance was observed.
Patient Sequence No: 1, Text Type: N, H10
[40136914]
A customer obtained a lower than expected ammonia quality control result (114. 79 umol/l vs. Expected result of 162. 8 umol/l) from a non-vitros quality control fluid, using vitros amon reagent with 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 lower than expected ammonia result was generated from non-patient fluids, however the investigation cannot conclude that patient sample results were not affected and would not be affected if the event were to recur undetected. There was no allegation of patient harm as a result of the event. This report corresponds to ortho clinical diagnostics inc. Complaint number (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319681-2016-00044 |
| MDR Report Key | 5485753 |
| Date Received | 2016-03-08 |
| Date of Report | 2016-03-08 |
| Date of Event | 2016-02-11 |
| Date Mfgr Received | 2016-02-14 |
| Device Manufacturer Date | 2014-03-29 |
| Date Added to Maude | 2016-03-08 |
| 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 | 2016-03-08 |
| 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 | 2016-03-08 |