MAUDE Adverse Event Report: FOCUS DIAGNOSTICS SIMPLEXA HSV 1 & 2 DIRECT, SIMPLEXA HSV 1 & 2 POSITIVE CONTROL PACK; HERPES SIMPLEX VIRUS NUCLEIC ACID AMPLIFICATION ASSAY

Model Number MOL2150

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/13/2016

Event Type  malfunction  

Event Description

Focus diagnostics has received a total of 34 complaints from 20 customers for early cycle threshold (ct) issues with the direct amplification disc (dad) (mol1455, mol1451, and mol 1452) while performing the simplexa hsv 1 & 2 direct assay.This error may result in a false positive result, a false negative result, and error code(s) giving an invalid run.Early internal testing reproduced the early ct threshold; however, these early ct were produced only when the dad was used after a previous partial run.The false result was not reported to the doctor.There was no patient involvement.A voluntary recall has been performed related to the reported lot.As of march 10, 2016, there has been no report of patient injury or death.

• Brand Name: SIMPLEXA HSV 1 & 2 DIRECT, SIMPLEXA HSV 1 & 2 POSITIVE CONTROL PACK
• Type of Device: HERPES SIMPLEX VIRUS NUCLEIC ACID AMPLIFICATION ASSAY
• Manufacturer (Section D): FOCUS DIAGNOSTICS; 11331 valley view street; cypress CA 90630
• Manufacturer (Section G): FOCUS DIAGNOSTICS; 11331 valley view street; cypress CA 90630
• Manufacturer Contact: valerie cimmarusti ; 11331 valley view street; cypress, CA 90630 ; 5622406484
• MDR Report Key: 5493888
• MDR Text Key: 40130617
• Report Number: 2023365-2016-00033
• Device Sequence Number: 1
• Product Code: OQO
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K150962
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 03/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Model Number: MOL2150
• Device Lot Number: 28908
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/13/2016
• Initial Date FDA Received: 03/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1