MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-24 for VITROS CHEMISTRY PRODUCTS GENT REAGENT 6801711 manufactured by Ortho-clinical Diagnostics.
[39424237]
The investigation determined that a lower than expected vitros gent result was obtained from a single patient sample processed using vitros gent reagent on a vitros 5600 integrated system. The investigation was unable to determine a definitive assignable cause. A pre-analytical sample handling issue has been ruled out as a contributing factor to the event. Although there is no evidence of a vitros gent reagent issue or instrument malfunction, due to limited data available neither can be ruled out as contributing factors to this event.
Patient Sequence No: 1, Text Type: N, H10
[39424238]
An ortho quality analyst observed a lower than expected vitros gent result (5. 55 ug/ml versus 9. 61, 9. 09 ug/ml) from a single patient sample processed in triplicate using vitros gent reagent on a vitros 5600 integrated system. The sample was not tested for clinical applications, but as part of an internal ortho validation plan. There was no allegation of patient harm as a result of this event. However, biased patient results of the direction and magnitude observed may lead to inappropriate physician action if occurred undetected on patient samples. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319808-2016-00002 |
| MDR Report Key | 5456487 |
| Date Received | 2016-02-24 |
| Date of Report | 2016-02-24 |
| Date of Event | 2016-01-06 |
| Date Mfgr Received | 2016-01-28 |
| Device Manufacturer Date | 2015-02-11 |
| Date Added to Maude | 2016-02-24 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JAMES A STEVENS |
| Manufacturer Street | 100 INDIGO CREEK DRIVE |
| Manufacturer City | ROCHESTER NY 14626 |
| Manufacturer Country | US |
| Manufacturer Postal | 14626 |
| Manufacturer Phone | 5854533000 |
| Manufacturer G1 | ORTHO-CLINICAL DIAGNOSTICS |
| Manufacturer Street | 1000 LEE ROAD |
| 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 | 0 |
| Brand Name | VITROS CHEMISTRY PRODUCTS GENT REAGENT |
| Generic Name | IN VITRO DIAGNOSTICS |
| Product Code | LCD |
| Date Received | 2016-02-24 |
| Catalog Number | 6801711 |
| Lot Number | 1512-09-4235 |
| Device Expiration Date | 2016-12-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORTHO-CLINICAL DIAGNOSTICS |
| Manufacturer Address | 1000 LEE ROAD ROCHESTER NY 14606 US 14606 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-02-24 |