MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-04-30 for VITROS CHEMISTRY PRODUCTS BENZ REAGENT PACK 680 1989 manufactured by Ortho-clinical Diagnostics, Inc..
[831757]
The customer obtained a false negative pt result using vitros benz reagent on the vitros 5,1 fs chemistry system. Confirmatory testing with gc/ms indicated the presence of a benzodiazepine compound. Biased results of the direction and magnitude observed may 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
[8004965]
Investigation into this event found that the vitros 5,1 and vitros benz reagent were operating as intended. The pt sample contained 7-amino-clonazepam at a concentration where a negative result is the expected result per the analytical specificity section of the vitros benz instructions for use.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319808-2008-00123 |
| MDR Report Key | 1039908 |
| Report Source | 05 |
| Date Received | 2008-04-30 |
| Date of Report | 2008-04-02 |
| Date of Event | 2008-03-24 |
| Date Mfgr Received | 2008-04-02 |
| Device Manufacturer Date | 2007-08-01 |
| Date Added to Maude | 2008-07-14 |
| 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 Street | 1000 LEE RD |
| Manufacturer City | ROCHESTER NY 14606 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 14606 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VITROS CHEMISTRY PRODUCTS BENZ REAGENT PACK |
| Generic Name | IN-VITRO DIAGNOSTIC |
| Product Code | JXM |
| Date Received | 2008-04-30 |
| 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 | 1037799 |
| Manufacturer | ORTHO-CLINICAL DIAGNOSTICS, INC. |
| Manufacturer Address | 100 INDIGO CREEK DR ROCHESTER NY 146265101 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-04-30 |