SOFIA FLUORESCENT IMMUNOASSAY ANALYZER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-03-20 for SOFIA FLUORESCENT IMMUNOASSAY ANALYZER manufactured by Quidel Corp.

Event Text Entries

[4270015] Our institution has been using the sofia fluorescent immunoassay analyzer (quidel corp. , (b)(4)) as our point-of-care test (poct) for influenza since 2013. We observed that (b)(6) percent of the positive tests resulted as influenza b, which is in great excess of the cdc-published average of 4-9 percent. Because we suspected the majority of the poct influenza b results were false positives, we conducted a study in which every positive poct test was immediately followed up with a second sample analyzed by our respiratory virus pcr panel (esensor, genmark dx, (b)(4)). Of (b)(6) poct specimens positive for flu b, (b)(6) percent were negative for the presence of any respiratory virus by pcr. Another (b)(6) percent were positive only for a non-influenza virus, such as rhinovirus, adenovirus, etc. Therefore, (b)(6) percent of the poct results for flu b were false positives. Of the remaining results, (b)(6) percent were found to be flu a (h1n1) by pcr, and only (b)(6) of the (b)(6) paired specimens was found to be influenza b by pcr. Because our clinical practice dictates prescription of neuraminidase inhibitors (principally oseltammivir) for flu pts, we believe that potentially (b)(6) percent of pts who received a poct result for influenza b were misdiagnosed, and inappropriately treated with a drug they did not need. As a result of these findings, we worked with the manufacturer on two occasions to make sure that the test was being performed correctly. Despite re-training by the manufacturer's representatives as well as our own staff, we saw no reduction in the percent positivity for flu b with this product. As a result, we informed the manufacturer that we will no longer use this product as our rapid test for influenza, and now solely rely upon pcr.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5035183
MDR Report Key3698110
Date Received2014-03-20
Date Added to Maude2014-03-26
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameSOFIA FLUORESCENT IMMUNOASSAY ANALYZER
Generic NamePOINT OF CARE RAPID FLU TEST
Product CodeGNX
Date Received2014-03-20
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Sequence No1
Device Event Key0
ManufacturerQUIDEL CORP
Manufacturer AddressSAN DIEGO CA US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2014-03-20

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