MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2003-04-16 for VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK 8435307 manufactured by Ortho-clinical Diagnostics.
[17027394]
A customer reported a repeat false negative result for hepatitis b surface antigen (hbsag) on one patient sample. A positive result was obtained by another manufacturer's assay. A false negative hbsag result could present a risk to public health. There was no report of patient harm as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680658-2003-00084 |
| MDR Report Key | 454511 |
| Report Source | 01,05 |
| Date Received | 2003-04-16 |
| Date of Report | 2003-03-20 |
| Date of Event | 2003-03-12 |
| Date Mfgr Received | 2003-03-20 |
| Device Manufacturer Date | 2002-10-01 |
| Date Added to Maude | 2003-04-21 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | CYNTHIA PETERS |
| Manufacturer Street | 100 INDIGO CREEK DRIVE |
| Manufacturer City | ROCHESTER NY 146265101 |
| Manufacturer Country | US |
| Manufacturer Postal | 146265101 |
| Manufacturer Phone | 5854533807 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK |
| Generic Name | IN VITRO DIAGNOSTIC |
| Product Code | LQI |
| Date Received | 2003-04-16 |
| Model Number | NA |
| Catalog Number | 8435307 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 443513 |
| Manufacturer | ORTHO-CLINICAL DIAGNOSTICS |
| Manufacturer Address | 100 INDIGO CREEK DRIVE ROCHESTER NY 146265101 US |
| Baseline Brand Name | VITORS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK |
| Baseline Generic Name | IN VIRRO DIAGNOSTIC |
| Baseline Model No | NA |
| Baseline Catalog No | 8435307 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-04-16 |