ZIKA VIRUS RNA QUALITATIVE REAL-TIME RT-PCR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-09 for ZIKA VIRUS RNA QUALITATIVE REAL-TIME RT-PCR manufactured by Focus Diagnostics, Inc..

Event Text Entries

[59886051] Results from different zika assays are discrepant. Focus diagnostics performed an investigation of the discrepant result which showed that there were not procedural nor material problems with the assay. Reagents were manufactured according to the established sop and no non-conformance was identified. Reagents were within expiration dating and showed no clear trends. Extraction and pcr runs/batches showed that all pcr ct values and amplification curves for the assay controls were valid. Pcr ct values and amplification curves for the pt specimens were properly interpreted as specified in the tsop focus discussed pts' clinical history and epidemiological risk factors, and f/u testing with the public health authorities, and based on the data provided, classified the discrepant as a suspected false positive result. Our investigation and analysis suggests the root causes for the discrepant result was due to a difference in assay performance when compared with the results generated by the cdc trioplex assay and the associated potential issues with reproducibility at low viral loads. Because of the low rate of false positive results focus did not believe that it was appropriate to change the design of the assay. Focus has made labeling changes to further communicate the risks of the assay. Specimen that was collected 11 days post onset symptoms was positive (ct 37. 01) and near the cut-off (ct 39) when tested with the focus zika virus rna qualitative real-time rt-pcr. Subsequent testing at the public health laboratory 16 days post-symptom onset were negative when tested with the public health laboratory molecular assays (cdc trioplex pcr assay, urine pcr and amniotic fluid pcr). Serum igm (cdc mac igm elisa) testing two weeks post onset of symptoms was negative. Remnant specimen was re-thawed and re-tested 37 days post-symptom onset and was negative with the focus zika virus rna qualitative real-time rt-pcr, which may indicate a de-graded specimen, however because of low reproducibility at low viral loads, this cannot be 100% confirmed. The specimen was dengue igg negative, indicating that the lack of igm response was not due to prior flavivirus infection.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5065965
• MDR Report Key: 6098769
• Date Received: 2016-11-09
• Date of Report: 2016-10-05
• Date of Event: 2016-07-27
• Date Added to Maude: 2016-11-14
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• 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: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: ZIKA VIRUS RNA QUALITATIVE REAL-TIME RT-PCR
• Generic Name: ZIKA VIRUS RNA QUALITATIVE REAL-TIME RT-PCR
• Product Code: POA
• Date Received: 2016-11-09
• Returned To Mfg: 2016-08-22
• Lot Number: 070616
• Device Expiration Date: 2017-07-06
• Device Availability: Y
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: FOCUS DIAGNOSTICS, INC.
• Manufacturer Address: 33608 ORTEGA HWY BLDG B SAN JUAN CAPISTRANO CA 92675 US 92675

Patients

Patient Number	Treatment	Outcome	Date
1	0		2016-11-09