ARCHITECT STAT MYOGLOBIN CALIBRATORS

Description of Event or Problem

THE CUSTOMER OBSERVED QUALITY CONTROLS (QC) WERE OUT OF RANGE HIGH PEER RANGE FROM APRIL ON MULTIPLE ASSAYS. EXAMPLES PROVIDED BY THE CUSTOMER WERE THAT TROPONIN AND MYOGLOBIN WERE OUT OF RANGE. THE FIELD SERVICE ENGINEER (FSE) WAS ONSITE AND CONDUCTED TROUBLESHOOTING OF THE CUSTOMER¿S ARCHITECT I2000SR ANALYZER. THE CUSTOMER REPORTED THAT ON (B)(6) 2022, THE MYOGLOBIN QC LEVEL 3 WAS STILL OUT OF PACKAGE INSERT RANGE WHEN USING THE ARCHITECT STAT MYOGLOBIN CALIBRATOR, LOT 166000. THE ISSUE WAS RESOLVED WHEN THE CUSTOMER SWITCHED TO A DIFFERENT CALIBRATOR LOT. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

Additional Manufacturer Narrative

THE INVESTIGATION INTO THIS ISSUE IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. A PRODUCT RECALL LETTER WAS SENT TO ALL CUSTOMERS WHO HAVE RECEIVED SHIPMENTS OF ARCHITECT STAT MYOGLOBIN CALIBRATORS LN 02K43-01, LOT 166000. THE PRODUCT RECALL LETTER NOTIFIES THE CUSTOMER OF THE ISSUE AND THE POTENTIAL IMPACT TO PATIENT RESULTS WITH USE OF THE IMPACTED LOT. THE PRODUCT RECALL LETTER INSTRUCTS CUSTOMERS TO IMMEDIATELY CONTACT CUSTOMER SUPPORT TO ORDER A REPLACEMENT PRODUCT AND TO DISCONTINUE USE OF AND DESTROY ANY REMAINING INVENTORY OF LOT 166000 ACCORDING TO THEIR LABORATORY PROCEDURES.

Additional Manufacturer Narrative

DURING THE INVESTIGATION INTO THIS ISSUE, IT WAS NOTED THAT AN EQUILIBRIUM SHIFT SEEN IN THE ARCHITECT MYOGLOBIN CALIBRATOR LOT 166000; WHICH WAS ATYPICAL COMPARED TO OTHER HISTORICAL LOTS. IT WAS FURTHER DETERMINED THAT THE ARCHITECT MYOGLOBIN CALIBRATOR LOT 166000 WAS NOT AT DOSE/RESPONSE EQUILIBRIUM AT THE TIME OF BULK S/C TESTING BECAUSE THE RLU PERFORMANCE DETERMINED AT THIS STAGE WAS NOT CONSERVED OVER TIME. THE INVESTIGATION ALSO IDENTIFIED THAT CALIBRATION PERFORMANCE DECLINED OVER TIME AS A NORMAL OCCURRENCE OF CALIBRATOR STABILITY. AS CALIBRATOR RLU PERFORMANCE DECREASES OVER TIME, SAMPLES READ OFF OF IT WILL TREND UPWARDS. TOGETHER THESE FINDINGS SHOWED THAT THE INITIAL EQUILIBRIUM SHIFT COMBINED WITH DECREASING CALIBRATOR RLU STABILITY PERFORMANCE EXISTED FOR CALIBRATOR LOT 166000, WHICH THAT LED TO THE STABILITY FAILURE. A PRODUCT RECALL LETTER WAS SENT TO ALL CUSTOMERS WHO HAVE RECEIVED SHIPMENTS OF ARCHITECT STAT MYOGLOBIN CALIBRATORS LN 02K43-01, LOT 166000. THE PRODUCT RECALL LETTER NOTIFIES THE CUSTOMER OF THE ISSUE AND THE POTENTIAL IMPACT TO PATIENT RESULTS WITH USE OF THE IMPACTED LOT. THE PRODUCT RECALL LETTER INSTRUCTS CUSTOMERS TO IMMEDIATELY CONTACT CUSTOMER SUPPORT TO ORDER A REPLACEMENT PRODUCT AND TO DISCONTINUE USE OF AND DESTROY ANY REMAINING INVENTORY OF LOT 166000 ACCORDING TO THEIR LABORATORY PROCEDURES. THIS SUPPLEMENTAL MDR IS BEING SUBMITTED TO INCLUDE THE INVESTIGATIONAL FINDINGS FOR THE ISSUE.