MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2006-06-12 for VITROS IMMUNODIAGNOSITC PRODUCTS HBSAG CONFIRMATORY KIT 8228595 manufactured by Ortho-clinical Diagnostics.
[559581]
A customer observed a false negative hbsag confirmatory test result on a patient sample on the eci analyzer. Positive results were obtained using an alternate method. The erroneous result was not reported. False negative hbsag confirmatory results 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
[8057576]
Investigation summary. Investigation into the event showed that the sample was hbsag confirmed positive by an alternate method confirmatory test. The initial confirmatory test produced neutralization of less than 50%. The customer did not complete the confirmatory testing as described in the instructions for use. Although a mutant strain of the virus has been identified in the case, the root cause of the false negative confirmatory test has not been identified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680658-2006-00130 |
| MDR Report Key | 812442 |
| Report Source | 01,05 |
| Date Received | 2006-06-12 |
| Date of Report | 2006-05-15 |
| Date Mfgr Received | 2006-05-15 |
| Device Manufacturer Date | 2005-12-01 |
| Date Added to Maude | 2007-02-07 |
| 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 | 0 |
| Manufacturer Contact | THOMAS SMITH |
| Manufacturer Street | 100 INDIGO CREEK DRIVE |
| Manufacturer City | ROCHESTER NY 146261501 |
| Manufacturer Country | US |
| Manufacturer Postal | 146261501 |
| Manufacturer Phone | 5854533735 |
| 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 IMMUNODIAGNOSITC PRODUCTS HBSAG CONFIRMATORY KIT |
| Generic Name | IN VITRO DIAGNOSTIC |
| Product Code | LDM |
| Date Received | 2006-06-12 |
| Model Number | NA |
| Catalog Number | 8228595 |
| Lot Number | 270 |
| ID Number | NA |
| Device Expiration Date | 2006-12-07 |
| 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 | 799927 |
| 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 | 2006-06-12 |