FDA Adverse Event Malfunction Summary report: N

SIMPLEXA FLU A/B AND RSV DIRECT ASSAY

MDR report key: 4379585 · Received December 29, 2014

Report

Report Number: 2023365-2014-00010
Event Type: Malfunction
Date Received: December 29, 2014
Date of Event: January 9, 2014
Report Date: January 10, 2014
Manufacturer: FOCUS DIAGNOSTICS, INC.
Product Code: OCC
PMA / PMN Number: K120413
Removal / Correction Number: Z-0846-2014
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NY, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

THE INVESTIGATION OF THE SIMPLEXA FLU A/B RSV DIRECT KIT (MOL2650) SUGGESTED THAT THE ROOT CAUSE FOR THE OCCURRENCE OF FALSE POSITIVE (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 QA 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. (B)(4).

Description of Event or Problem · 1

THE CUSTOMER REPORTED LOW LEVEL RSV VALUES ON PT SAMPLES. THE RSV DID CROSS THE THRESHOLD AND THE SOFTWARE INDICATED "DETECTED". THE LABORATORY DID NOT REPORT THE RSV POSITIVE RESULTS. A VOLUNTARY RECALL HAS BEEN PERFORMED RELATED TO THE REPORTED LOT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
855454	SIMPLEXA FLU A/B AND RSV DIRECT ASSAY	IN-VITRO-DIAGNOTIC TEST, INFLUENZA	OCC	FOCUS DIAGNOSTICS, INC.	MOL2650	24493

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK