MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-03-12 for VITROS 5,1 FS CHEMISTRY SYSTEM 6801375 manufactured by Ortho-clinical Diagnostics.
[1197388]
The customer obtained negatively biased phyt results from a single pt sample using vitros phyt slides on a vitros 5,1 fs chemistry system. Biased results of the direction and magnitude observed may lead to inappropriate physician action. The biased results were reported, however, there were no allegations of harm. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[8331691]
The investigation determined that phyt quality control results were acceptable at the time of the event. The investigation found no evidence to suggest that either the vitros 5,1 or the vitros phyt slides had malfunctioned. The root cause of the biased phyt result could not be determined, however, pre-analytical error resulting in a short filled sample tube and poor sample quality cannot be ruled out.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319681-2009-00061 |
| MDR Report Key | 1396813 |
| Report Source | 05 |
| Date Received | 2009-03-12 |
| Date of Report | 2009-02-12 |
| Date of Event | 2009-02-11 |
| Date Mfgr Received | 2009-02-12 |
| Device Manufacturer Date | 2005-09-01 |
| Date Added to Maude | 2010-02-02 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JOE FALVO |
| Manufacturer Street | 100 INDIGO CREEK DR. |
| Manufacturer City | ROCHESTER NY 146265101 |
| Manufacturer Country | US |
| Manufacturer Postal | 146265101 |
| Manufacturer Phone | 5854535735 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VITROS 5,1 FS CHEMISTRY SYSTEM |
| Generic Name | CHEMISTRY ANALYZER |
| Product Code | DKH |
| Date Received | 2009-03-12 |
| Model Number | NA |
| Catalog Number | 6801375 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORTHO-CLINICAL DIAGNOSTICS |
| Manufacturer Address | 100 INDIGO CREEK DR. ROCHESTER NY 14626510 US 14626 5101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-03-12 |