MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-08-13 for VITROS 350 CHEMISTRY SYSTEM 6802153 manufactured by Ortho-clinical Diagnostics.
[18226884]
A customer obtained non-reproducible, negatively biased vitros phyt results for one pt sample on the vitros 350 analyzer. The results were reported out of the laboratory. Biased results of the direction and magnitude observed could lead to inappropriate physician action. There was no report of pt harm as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[18385836]
The investigation determined that the analyzer was operating as intended. There is no evidence to suggest that phyt reagent lot is not operating as intended. The root cause of the unexpected phyt result is unk.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319681-2008-00238 |
| MDR Report Key | 1122792 |
| Report Source | 05 |
| Date Received | 2008-08-13 |
| Date of Report | 2008-07-16 |
| Date of Event | 2008-07-16 |
| Date Mfgr Received | 2008-07-16 |
| Device Manufacturer Date | 2006-07-01 |
| Date Added to Maude | 2009-11-03 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JOSEPH 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 350 CHEMISTRY SYSTEM |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | DKH |
| Date Received | 2008-08-13 |
| Model Number | NA |
| Catalog Number | 6802153 |
| 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 | 2008-08-13 |