FDA Adverse Event Malfunction Summary report: N

SIMPLEXA FLU A/B AND RSV DIRECT ASSAY

MDR report key: 4379491 · Received December 29, 2014

Report

Report Number: 2023365-2014-00039
Event Type: Malfunction
Date Received: December 29, 2014
Date of Event: February 18, 2014
Report Date: February 18, 2014
Manufacturer: FOCUS DIAGNOSTICS, INC.
Product Code: OCC
PMA / PMN Number: K120413
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MN, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

THERE WERE NO MORE SAMPLES (PATIENT SPECIMEN OR REACTION MIX) THAT COULD BE RETURNED FOR TESTING. A RETAIN SAMPLE FROM THE REPORTED LOT (LN 24160) WAS TESTED. (B)(4). NO FALSE POSITIVE RESULTS WERE OBSERVED. ONE HUNDRED PERCENT OF THE NTC REPLICATES WERE NEGATIVE FOR ALL ANALYTES AND THE RNA INTERNAL CONTROL WAS DETECTED. NO PROBLEMS WERE OBSERVED DURING TESTING. (B)(4).

Description of Event or Problem · 1

THE CUSTOMER INITIALLY REPORTED THAT THE HAD THREE FALSE POSITIVE RESULTS. SUBSEQUENT INFORMATION STATED THAT THERE WERE 6 SAMPLES THAT TESTED POSITIVE AND THEN CAME UP NEGATIVE. THEY SENT THE POSITIVE SAMPLES TO THEIR LOCAL PUBLIC HEALTH LABORATORY AND THE PUBLIC HEALTH LAB FOUND THE SAMPLES TO BE NEGATIVE. THE STATE LAB PERFORMED A MOLECULAR METHOD (RT-PCR) FOR CONFIRMATION AND STATED THAT IT IS A MODIFIED FDA TEST. THE LABORATORY REPORTED THE FALSE POSITIVE RESULTS TO THE DOCTOR. THIS SUPPLEMENTAL MDR IS FOR THE FIRST OF THE SIX FALSE POSITIVE RESULTS THAT WERE REPORTED TO THE DOCTOR. FIVE ADDITIONAL MDRS ARE BEING SUBMITTED REMAINING EVENTS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
854685	SIMPLEXA FLU A/B AND RSV DIRECT ASSAY	IN-VITRO-DIAGNOSTIC TEST, INFLUENZA	OCC	FOCUS DIAGNOSTICS, INC.	MOL2650	24160

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK