SIMPLEXA FLU A/B & RSV DIRECT AND SIMPLEXA FLU A/B & RSV POSITIVE CONTROL MOL2650 NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-03-04 for SIMPLEXA FLU A/B & RSV DIRECT AND SIMPLEXA FLU A/B & RSV POSITIVE CONTROL MOL2650 NA manufactured by Focus Diagnostics.

Event Text Entries

[39755559] Focus diagnostics has received a total of (b)(4) 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 flu a/b & rsv 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 4, 2016, there has been no report of patient injury or death.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2023365-2016-00012
MDR Report Key5481831
Report SourceHEALTH PROFESSIONAL
Date Received2016-03-04
Date of Report2016-03-04
Date of Event2016-01-11
Date Mfgr Received2016-01-11
Date Added to Maude2016-03-04
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMRS VALERIE CIMMARUSTI
Manufacturer Street11331 VALLEY VIEW STREET
Manufacturer CityCYPRESS CA 90630
Manufacturer CountryUS
Manufacturer Postal90630
Manufacturer Phone5622406484
Manufacturer G1FOCUS DIAGNOSTICS
Manufacturer Street11331 VALLEY VIEW STREET
Manufacturer CityCYPRESS CA 90630
Manufacturer CountryUS
Manufacturer Postal Code90630
Single Use3
Remedial ActionNO
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSIMPLEXA FLU A/B & RSV DIRECT AND SIMPLEXA FLU A/B & RSV POSITIVE CONTROL
Generic NameRESPIRATORY VIRUS PANEL NUCLEIC ACID ASSAY SYSTEM
Product CodeOCC
Date Received2016-03-04
Model NumberMOL2650
Catalog NumberNA
Lot Number29845
OperatorOTHER HEALTH CARE PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerFOCUS DIAGNOSTICS
Manufacturer Address11331 VALLEY VIEW STREET CYPRESS CA 90630 US 90630


Patients

Patient NumberTreatmentOutcomeDate
10 2016-03-04

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