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 2008-06-17 for VITROS IMMUNODIAGNOSTIC PRODUCTS AHIV REAGENT PACK 1241850 manufactured by Ortho-clinical Diagnostics.
[21990351]
Investigation into this event found that a negative vitros result was obtained for a patient sample drawn from a reactive patient. The patient sample involved in this event is no longer available. A request has been made to obtain an additional sample from this patient for further testing at ortho-clinical diagnostics. The vitros eci analyzer was performing as expected. The root cause of this event unknown.
Patient Sequence No: 1, Text Type: N, H10
[22072882]
A customer observed a reproducible negatively biased a result for a patient sample using the vitros eci. The patient results were not reported to the clinician. There was no report of patient harm as a result of this event. This report corresponds to ortho clinical diagnostics inc.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680658-2008-00187 |
| MDR Report Key | 1062975 |
| Report Source | 00,01,05 |
| Date Received | 2008-06-17 |
| Date of Report | 2008-05-07 |
| Date of Event | 2008-05-05 |
| Date Mfgr Received | 2008-05-07 |
| Device Manufacturer Date | 2007-11-01 |
| Date Added to Maude | 2009-10-29 |
| 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 DRIVE |
| Manufacturer City | ROCHESTER NY 146265101 |
| Manufacturer Country | US |
| Manufacturer Postal | 146265101 |
| Manufacturer Phone | 5854535735 |
| Manufacturer G1 | FOREST FARM ESTATE |
| Manufacturer Street | WHITCHURCH |
| Manufacturer City | CARDIFF CF147YT |
| Manufacturer Country | UK |
| Manufacturer Postal Code | CF14 7YT |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VITROS IMMUNODIAGNOSTIC PRODUCTS AHIV REAGENT PACK |
| Generic Name | IN VITRO DIAGNOSTIC |
| Product Code | MTL |
| Date Received | 2008-06-17 |
| Model Number | NA |
| Catalog Number | 1241850 |
| Lot Number | 1942 |
| ID Number | NA |
| Device Expiration Date | 2008-08-04 |
| 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 DRIVE ROCHESTER NY 14626510 US 14626 5101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-06-17 |