MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,05 report with the FDA on 2009-10-21 for VITROS 350 CHEMISTRY SYSTEM 6802153 manufactured by Ortho-clinical Diagnostics, Inc..
[1329070]
The customer obtained falsely elevated, non-reproducible results on two pt samples processed using vitros amon slides on a vitros 350 chemistry system. Biased results of the direction and magnitude observed may lead to inappropriate physician action. The falsely elevated results were not reported outside the lab. There was no report of pt harm as a result of this event. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[8421582]
Ocd field service investigated. The incubator was cleaned and the incubator evaporation caps were replaced, returning the vitros 350 to expected operation. The root cause of this event is instrument related.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319681-2009-00333 |
| MDR Report Key | 1514201 |
| Report Source | 00,01,05 |
| Date Received | 2009-10-21 |
| Date of Report | 2009-09-22 |
| Date of Event | 2009-09-20 |
| Date Mfgr Received | 2009-09-22 |
| Device Manufacturer Date | 2005-04-01 |
| Date Added to Maude | 2010-03-09 |
| 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 350 CHEMISTRY SYSTEM |
| Generic Name | CHEMISTRY SYSTEM |
| Product Code | JIF |
| Date Received | 2009-10-21 |
| 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, INC. |
| Manufacturer Address | 100 INDIGO CREEK DR. ROCHESTER NY 14626510 US 14626 5101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-10-21 |