MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2002-12-20 for VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONFIRMATORY REGENT 8228595 manufactured by Ortho-clinical Diagnostics.
[17420806]
The customer obtained a false negative interpretation for a hbv positive patient sample using the hbsag confirmatory kit. The sample was retested using the correct protocol and a positive result was obtained. A false negative result could cause the physician not to initiate proper treatment or present a risk to public health. The cause of this event is user error (failure to follow protocol provided in package insert). No false negative results were reported. There was no report of patient harm or change to patient treatment as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680658-2002-00204 |
| MDR Report Key | 434540 |
| Report Source | 01,05 |
| Date Received | 2002-12-20 |
| Date of Report | 2002-11-21 |
| Date of Event | 2002-11-21 |
| Date Mfgr Received | 2002-11-21 |
| Device Manufacturer Date | 2001-11-01 |
| Date Added to Maude | 2002-12-30 |
| 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 CONFIRMATORY REGENT |
| Generic Name | IN VITRO DIAGNOSTIC |
| Product Code | LDM |
| Date Received | 2002-12-20 |
| Model Number | NA |
| Catalog Number | 8228595 |
| Lot Number | 121 |
| ID Number | NA |
| Device Expiration Date | 2002-08-29 |
| 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 | 423493 |
| Manufacturer | ORTHO-CLINICAL DIAGNOSTICS |
| Manufacturer Address | 100 INDIGO CREEK DRIVE ROCHESTER NY 146265101 US |
| Baseline Brand Name | VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONFIRMATORY KIT |
| Baseline Generic Name | HBSAG CONFIRMATORY KIT ASSAY |
| Baseline Model No | NA |
| Baseline Catalog No | 8228595 |
| Baseline ID | NA |
| Baseline Device Family | VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONFIRMATORY KIT |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 10 |
| Baseline PMA Flag | Y |
| Premarket Approval | P0000 |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2002-12-20 |