MAUDE Adverse Event Report: FOCUS DIAGNOSTICS, INC. HERPESELECT 2 ELISA IGG; HERPES SIMPLEX VIRUS SER. ASSAY

Model Number EL0920G

Device Problem False Negative Result (1225)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/17/2011

Event Type  malfunction  

Event Description

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.

Manufacturer Narrative

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.

• Brand Name: HERPESELECT 2 ELISA IGG
• Type of Device: HERPES SIMPLEX VIRUS SER. ASSAY
• Manufacturer (Section D): FOCUS DIAGNOSTICS, INC.; cypress CA
• Manufacturer Contact: valerie cimmarusti, cls ; 11331 valley view st.; cypress, CA 90630 ; 5622406484
• MDR Report Key: 4379411
• MDR Text Key: 5119729
• Report Number: 2023365-2014-00053
• Device Sequence Number: 1
• Product Code: MXJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021486
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/01/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2012
• Device Model Number: EL0920G
• Device Catalogue Number: EL0920G
• Device Lot Number: 113148
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2011
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1