MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-12-29 for HERPESELECT 2 ELISA IGG EL0920G manufactured by Focus Diagnostics, Inc..
[5119729]
The physician reported that the assay was run on (b)(6) 2011 and the initial result was (b)(6) with an index 2. 88. The assay was run again on (b)(6) 2011 and the result was (b)(6) with an index of 0. 06. The patient sample was stored at -20c (serum separated) between (b)(6) 2011. Both assays were run using the same kit lot. Both (b)(6) results were reported to the doctor, with a span of approximately 2 weeks between the reports. It is unknown if the patient received treatment based on the (b)(6) test result. This mdr is being reported for a possible (b)(6) test result from the tests performed on (b)(6) 2011 for the (b)(6). This is a conservative decision, based on the fact that needed treatment might be discontinued. If the patient was pregnant, it may result in serious indirect harm to the fetus. The patient information is unknown.
Patient Sequence No: 1, Text Type: D, B5
[12633303]
Review of the device history record found no non-conformance material reports of discrepancies during the manufacture of the lot. No complaint trends were observed with the catalog number or for the lot. The customer's run files were reviewed and the kit controls were functioning per the qc performance criteria. No discrepancies were observed with the kit chemistry. The customer was advised to troubleshoot the dsx automation with respect to the pipetting of samples. The customer was also advised to repeat the run manually, preferably in duplicate or triplicate. The lab supervisor agreed with the analysis. The user is responsible for assay performance when an automated system is used.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2023365-2014-00053 |
| MDR Report Key | 4379411 |
| Report Source | 05 |
| Date Received | 2014-12-29 |
| Date of Report | 2011-12-01 |
| Date of Event | 2011-11-17 |
| Date Mfgr Received | 2011-12-01 |
| Device Manufacturer Date | 2011-09-01 |
| Date Added to Maude | 2015-01-23 |
| 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 | VALERIE CIMMARUSTI, CLS |
| Manufacturer Street | 11331 VALLEY VIEW ST. |
| Manufacturer City | CYPRESS CA 90630 |
| Manufacturer Country | US |
| Manufacturer Postal | 90630 |
| Manufacturer Phone | 5622406484 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HERPESELECT 2 ELISA IGG |
| Generic Name | HERPES SIMPLEX VIRUS SER. ASSAY |
| Product Code | MXJ |
| Date Received | 2014-12-29 |
| Model Number | EL0920G |
| Catalog Number | EL0920G |
| Lot Number | 113148 |
| ID Number | NA |
| Device Expiration Date | 2012-08-31 |
| Operator | HEALTH PROFESSIONAL |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-12-29 |