MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-01-11 for VITROS CHEMISTRY PRODUCTS BENZ REAGENT 680 1989 manufactured by Ortho-clinical Diagnostics, Inc..
[745927]
The customer obtained false negative vitros benz results on a single patient sample during a method comparison between the vitros 5, 1 fs chemistry system and a competitive system. Biased results of the direction and magnitude observed could lead to inappropriate physician action. The biased results were not reported and there was no report of patient harm as a result of this event. The report corresponds to ortho clinical diagnostics inc.
Patient Sequence No: 1, Text Type: D, B5
[8037821]
The investigation determined that the vitros 5,1 fs was operating as intended. The false negative vitros benz results were obtained during a method comparison with a competitive system. The samples used were admixtures of multiple patient samples. The definitive root cause is unknown, however, it is possible that pre-analytical sample mixup occurred during the admixture process, although this could not be proven.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319808-2008-00007 |
| MDR Report Key | 977692 |
| Report Source | 05 |
| Date Received | 2008-01-11 |
| Date of Report | 2007-12-13 |
| Date of Event | 2007-12-03 |
| Date Mfgr Received | 2007-12-13 |
| Device Manufacturer Date | 2007-08-01 |
| Date Added to Maude | 2008-11-07 |
| 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 |
| Manufacturer G1 | ORTHO-CLINICAL DIAGNOSTICS, INC. |
| Manufacturer Street | 6010 LEE RD. |
| Manufacturer City | ROCHESTER NY 14652310 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 14652 3104 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VITROS CHEMISTRY PRODUCTS BENZ REAGENT |
| Generic Name | IN-VITRO DIAGNOSTIC |
| Product Code | JXM |
| Date Received | 2008-01-11 |
| Model Number | NA |
| Catalog Number | 680 1989 |
| Lot Number | 1523-02-7634 |
| ID Number | NA |
| Device Expiration Date | 2008-07-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 980163 |
| Manufacturer | ORTHO-CLINICAL DIAGNOSTICS, INC. |
| Manufacturer Address | 100 INDIGO CREEK DR. ROCHESTER NY 146265101 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-01-11 |