MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-23 for VITROS 5600 INTEGRATED SYSTEM 6802413 manufactured by Ortho-clinical Diagnostics.
[90797450]
The investigation determined lower than expected vitros dgxn quality control results were obtained from two different quality control fluids on a vitros 5600 integrated system. The most likely assignable cause is instrument related. Prior to service actions performed by an ortho fe the within-run dgxn precision test was outside of ortho guidelines indicating the vitros 5600 integrated system was not performing as intended. Acceptable within-run precision dgxn results were obtained after service actions which included the replacement of the immuno rate re-insert blade motor, immuno rate wash cam, reflectometer optics, and all associated adjustments. ; indicating an instrument related issue is the likely assignable cause of the event. The investigation found no evidence the vitros dgxn reagent malfunctioned. Acceptable performance was observed when processing the quality control fluids after the completion of service actions.
Patient Sequence No: 1, Text Type: N, H10
[90797451]
A customer observed lower than expected vitros dgxn quality control results obtained from a non-vitros biorad control and a vitros tdm performance verifier iii control fluid on a vitros 5600 integrated system. Biorad liquichek immunoassay plus control, lot 47903 vitros dgxn result 1. 98 ng/ml versus biorad peer group mean 2. 69 ng/ml. Vitros tdm performance verifier iii lot h5125 result 1. 88 ng/ml versus the midpoint of the range of means (rom) 2. 8 ng/ml. Biased results of the magnitude and direction observed may lead to inappropriate physician action if patient samples were affected. Patient samples were not tested for vitros dgxn while quality control results were outside of expected ranges, however, the investigation could not rule out that patient samples 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. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319681-2017-00093 |
| MDR Report Key | 6968366 |
| Date Received | 2017-10-23 |
| Date of Report | 2017-10-23 |
| Date of Event | 2017-09-28 |
| Date Mfgr Received | 2017-09-28 |
| Device Manufacturer Date | 2011-03-15 |
| Date Added to Maude | 2017-10-23 |
| 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 | 2017-10-23 |
| 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 | 2017-10-23 |