FDA Adverse Event Malfunction Summary report: N

SIMPLEXA FLU A/B AND RSV DIRECT ASSAY

MDR report key: 4379428 · Received December 29, 2014

Report

Report Number: 2023365-2014-00051
Event Type: Malfunction
Date Received: December 29, 2014
Date of Event: November 1, 2013
Report Date: November 2, 2013
Manufacturer: FOCUS DIAGNOSTICS, INC.
Product Code: OCC
PMA / PMN Number: K120413
Removal / Correction Number: Z-1958-2014
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NY, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

INVESTIGATION DETERMINED THAT CARRY-OVER CONTAMINATION FROM SUCCESSIVE RUNS CAN OCCUR IF THE END-USER STORES THE DAD (DIRECT AMPLIFICATION DISC) VERTICALLY (I.E. ON EDGE). STORAGE OF THE DAD IN ANY VERTICAL POSITION AFTER INITIAL USE HAS A POTENTIAL OF ALLOWING FLUID TO TRAVEL BACK THROUGH THE CHANNELS AND CONTAMINATE OTHER UNUSED WEDGES. THIS MAY RESULT IN OBTAINING FALSE POSITIVE RESULTS. THE PRODUCT INSERT WARNING AND PRECAUTIONS SECTION HAS BEEN REVISED TO INCLUDE THE FOLLOWING ITEM: "AFTER EACH USE STORE DAD DISCS FLAT WITH THE NUMBERED FOIL SIDE UP." (B)(4).

Description of Event or Problem · 1

THE CUSTOMER REPORTED THAT THEY ARE HAVING TOO MANY INVALID INTERNAL CONTROL VALUES ON THE PATIENT SAMPLES. NO RESULTS WERE REPORTED TO THE DOCTOR AS THEY WERE UNABLE TO OBTAIN READINGS. REVIEW OF THE CUSTOMER'S RUN DATABASE FOUND FOUR INVALID SAMPLES IN ONE RUN. THE SAMPLES WERE VALID UPON REPEAT TESTING USING THE SAME LOT OF REAGENTS. THE PRODUCT INSERT WAS REVISED TO ADVISE THE END-USER THAT "AFTER EACH USE STORE DAD DISCS FLAT WITH THE NUMBERED FOIL SIDE UP."

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
854717	SIMPLEXA FLU A/B AND RSV DIRECT ASSAY	IN-VITRO-DIAGNOSTIC TEST, INFLUENZA	OCC	FOCUS DIAGNOSTICS, INC.	MOL2650	23784

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK