MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2007-12-21 for HERPESELECT 1 AND 2 HSV IMMUNOBLOT IB0900G manufactured by Focus Diagnostics, Inc..
[21363305]
Focus diagnostics rec'd a complaint that the hsv common antigen band of the herpeselect 1 and 2 hsv immumnoblot igg (b)(4) appeared lighter (less reactive) than the reading control ban. Reduced reactivity of the common antigen band may lead to the inaccurate interpretation of a sample as negative. In the specific case of the complaint the pt result was reported as indeterminate.
Patient Sequence No: 1, Text Type: D, B5
[21534756]
A definitive root cause has not been determined at this time. Early investigation indicates that the antigen lot may be at issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2023365-2007-00001 |
| MDR Report Key | 2136393 |
| Report Source | 06 |
| Date Received | 2007-12-21 |
| Date of Report | 2007-12-21 |
| Date of Event | 2007-11-21 |
| Date Mfgr Received | 2007-11-21 |
| Device Manufacturer Date | 2007-08-01 |
| Date Added to Maude | 2011-06-27 |
| 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 | CONSTANCE BRIDGES, DIR |
| Manufacturer Street | 10703 PROGRESS WAY |
| Manufacturer City | CYPRESS CA 90630 |
| Manufacturer Country | US |
| Manufacturer Postal | 90630 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HERPESELECT 1 AND 2 HSV IMMUNOBLOT |
| Generic Name | IMMUNOBLOT |
| Product Code | LGC |
| Date Received | 2007-12-21 |
| Model Number | IB0900G |
| Catalog Number | IB0900G |
| Lot Number | 072216 |
| Device Expiration Date | 2008-04-30 |
| Operator | OTHER |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FOCUS DIAGNOSTICS, INC. |
| Manufacturer Address | CYPRESS CA 90630 US 90630 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-12-21 |