MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2007-12-17 for HERPESELECT 1 AND 2 HSV IMMUNOBLOT IB0900G manufactured by Focus Diagnostics, Inc..
[21755038]
Focus diagnostics rec'd two complaints regarding the common band of the herpeselect immunoblot igg (ib0900g). The customer reported that the (b)(6) common antigen band appeared (b)(6) than the reading control band. Reduced reactivity of the common antigen band may lead to the inaccurate interpretation of a sample as (b)(6).
Patient Sequence No: 1, Text Type: D, B5
[21857876]
During the (b)(4) clinical trail several samples were (b)(6) in immunoblot, but (b)(6) on two other methods (b)(6). The frequency of these samples was approx (b)(6) of the samples tested). Statistical analysis demonstrated that the kit lot performed within the confidence internal of the performance characteristics as defined in the package insert. Post clinical trial, two complaints were rec'd that the (b)(6) antigen band was lighter (b)(6) than the (b)(4) reading control band on the same kit lot of immunoblot used in the clinical trial. The initial investigation indicated that the clinical trial samples were early (b)(6) which later sero-converted to (b)(6). Therefore a mdr report was not filed. Add'l investigation found that this explanation did not account for all samples. Further investigation determined that multiple freeze-thaws of the common antigen contributed to the malfunction. To address the situation, the package insert for the product ib0900g was revised to include a retest warning. The immunoblot common antigen has been stored in single use aliquots. Mfg documents will be revised to restrict freeze thaws on antigen preps. A blended sera which mimics the less reactive common antigen band on affected lots has been added to the quality control panel and will be used to qualify antigen preparations and to release final product.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2023365-2007-00003 |
| MDR Report Key | 2304516 |
| Report Source | 06 |
| Date Received | 2007-12-17 |
| Date of Report | 2007-12-05 |
| Date of Event | 2007-04-25 |
| Date Mfgr Received | 2011-02-20 |
| Device Manufacturer Date | 2007-01-01 |
| Date Added to Maude | 2011-10-28 |
| 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, DIRECTOR |
| Manufacturer Street | 10703 PROGRESS WAY |
| Manufacturer City | CYPRESS CA 90630 |
| Manufacturer Country | US |
| Manufacturer Postal | 90630 |
| Manufacturer Phone | 7142201900 |
| Single Use | 3 |
| Remedial Action | NO |
| 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 | 2007-12-17 |
| Model Number | IB0900G |
| Catalog Number | IB0900G |
| Lot Number | 063169 |
| Device Expiration Date | 2007-12-31 |
| Operator | OTHER |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2007-12-17 |