MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-05-11 for VITROS 5,1 FS CHEMISTRY ANALYZER 6801375 manufactured by Ortho-clinical Diagnostics.
[1214510]
A customer observed negatively biased acet results on the vitros 5,1 analyzer. Biased results were not released. Biased results of the magnitude and direction observed may lead to inappropriate physician action. There was no report of pt harm as a result of this event. (b) (4).
Patient Sequence No: 1, Text Type: D, B5
[8353579]
Investigation into this event concludes that the issue was confined to one level of quality control and one cartridge of acet slides. Pt sample results and the other level of quality control fluid were not affected. Replacing the acet slide cartridge produced expected acet results. The root cause of the event is unk.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319681-2009-00136 |
| MDR Report Key | 1432704 |
| Report Source | 05 |
| Date Received | 2009-05-11 |
| Date of Report | 2009-04-13 |
| Date of Event | 2009-04-10 |
| Date Mfgr Received | 2009-04-13 |
| Device Manufacturer Date | 2005-08-01 |
| Date Added to Maude | 2010-03-16 |
| 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 | 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 5,1 FS CHEMISTRY ANALYZER |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | LDP |
| Date Received | 2009-05-11 |
| 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 | 2009-05-11 |