SIMPLEXA FLU A/B AND RSV DIRECT ASSAY MOL2650

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-12-29 for SIMPLEXA FLU A/B AND RSV DIRECT ASSAY MOL2650 manufactured by Focus Diagnostics, Inc..

Event Text Entries

[5115983] The customer reported that they had an initial false positive rsv result. The laboratory reported the results to the doctor. The customer received the safety notice and the test was repeated using a different lot number. A corrective report was sent to the doctor. A voluntary recall has been performed related to the reported lot.
Patient Sequence No: 1, Text Type: D, B5


[12634518] The investigation of the simplexa flu a/b and rsv direct kit (mol2650) suggested that the root cause for the occurrence of false positives (and sub-amplifications) were due to the lot to lot variability of the scorpion primers. To mitigate the occurrence of false positives (and sub-amplifications), focus dx replaced the recombinant taq polymerase used in the mol2651 reaction mix with hot-start taq polymerase and reduced production time following bulk mol2651 formulation to 2 hours. Additionally, focus dx now employs more extensive testing with no template control (ntc) in the qc kit release criteria. These corrective and preventative actions are effective in mitigating the effects posed by the potential lot to lot variability of the scorpions. Manufacturer reference #: (b)(4).
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2023365-2014-00038
MDR Report Key4379502
Report Source05
Date Received2014-12-29
Date of Report2014-01-13
Date of Event2014-01-13
Date Mfgr Received2014-02-03
Device Manufacturer Date2014-01-01
Date Added to Maude2015-01-14
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactVALERIE CIMMARUSTI, CLS
Manufacturer Street11331 VALLEY VIEW ST.
Manufacturer CityCYPRESS CA 90630
Manufacturer CountryUS
Manufacturer Postal90630
Manufacturer Phone5622406484
Single Use3
Remedial ActionRC
Previous Use Code3
Removal Correction NumberZ-1144-2014
Event Type3
Type of Report3

Device Details

Brand NameSIMPLEXA FLU A/B AND RSV DIRECT ASSAY
Generic NameIN-VITRO-DIAGNOSTIC TEST, INFLUENZA
Product CodeOCC
Date Received2014-12-29
Model NumberMOL2650
Catalog NumberMOL2650
Lot Number24536
ID NumberNA
Device Expiration Date2015-01-31
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerFOCUS DIAGNOSTICS, INC.
Manufacturer AddressCYPRESS CA US


Patients

Patient NumberTreatmentOutcomeDate
10 2014-12-29

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