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Patient 1
CATALOG #: A32451 IS THE IDENTIFIER USED FOR CUSTOMERS TO ORDER THE ONCOMINE DX TARGET TEST. IT IS CONSIDERED A "LOT MANAGED SKU" WHICH IS NOT HELD IN INVENTORY, BUT PROVIDES INSTRUCTION REGARDING WHICH PRODUCTS WILL SHIP FOR THE CUSTOMER ORDER. THE ONCOMINE DX TARGET TEST RNA/DNA PANEL IS ONLY SHIPPED AS PART OF CATALOG #: A32451, BUT FOR TRACEABILITY PURPOSES, HAS IT'S OWN PRODUCT IDENTIFIERS: ONCOMINE DX TARGET TEST RNA/DNA PANEL, CATALOG #: A32441, LOT #: 1705001, (B)(4). SINCE THE ONCOMINE DX TARGET TEST RNA/DNA PANEL CAN ONLY BE ORDERED AS PART OF THE ONCOMINE DX TARGET TEST (CATALOG #: A32451), THE ONCOMINE DX TARGET TEST IS CONSIDERED THE AFFECTED PRODUCT IN THE FIELD. THE DATE RECEIVED BY MANUFACTURER IS CONSIDERED FEBRUARY 13, 2018. THIS IS THE DATE THE CLINICAL RELEVANCE OF THE LOW OLIGONUCLEOTIDE CONCENTRATION BECAME AVAILABLE. ON FEBRUARY 13, 2018 INFORMATION REGARDING POSSIBLE FALSE NEGATIVES OR "NO CALLS" IN THE FIELD WERE REPORTED BY THERMO FISHER SCIENTIFIC R&D TO THE INVESTIGATION TEAM. FEBRUARY 13, 2018 IS CONSIDERED THE DATE THERMO FISHER SCIENTIFIC BECAME AWARE OF A MDR REPORTABLE EVENT. MANUFACTURER NARRATIVE: THE ROOT CAUSE OF THE LOW OLIGONUCLEOTIDE CONCENTRATION IN THE ONCOMINE DX TARGET RNA/DNA PANEL (CATALOG #: A32441) HAS BEEN DETERMINED TO BE THE INADVERTENT ADDITION OF THE DEIONIZED WATER DURING FILLING OF THE BULK RNA OLIGO SOLUTION DURING THE LOT MANUFACTURING PROCESS. BULK OLIGO SOLUTION WAS THAWED, VORTEXED AND THEN CENTRIFUGED USING A COUNTERWEIGHT CONTAINING DI WATER. THE OPERATOR MISTAKENLY POURED DI WATER FROM THE COUNTERWEIGHT INTO THE FILL RESERVOIR INSTEAD OF THE BULK OLIGO SOLUTION TO COMPLETE THE PIPETTING AND FILL/FINISH PROCESS OF THE RNA PANEL. CUSTOMERS WERE NOTIFIED OF THE ISSUE ON FEBRUARY 16, 2018 AND INSTRUCTED TO REVIEW ANY PATIENT TEST RESULTS OBTAINED USING THE DEFECTIVE PRODUCT. CUSTOMERS WERE ADVISED TO RETEST PATIENT SAMPLES WHICH RESULTED IN A "NO CALL" OR NEGATIVE RESULT FOR A ROS1 VARIANT USING AN ALTERNATIVE TEST METHOD IF ONE WAS NOT PREVIOUSLY PERFORMED. PATIENTS TESTED WITH THE DEFECTIVE RNA PANEL MAY BE AT RISK FOR RECEIVING A FALSE NEGATIVE RESULT. ONLY PATIENTS WITH A ROS1 VARIANT (1%-2% OF THE PATIENT POPULATION) WOULD BE AT RISK FOR A FALSE NEGATIVE RESULT AND POSSIBLY BE EXCLUDED FROM TREATMENT WITH XALKORI.