ARCHITECT STAT MYOGLOBIN CALIBRATORS

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.

Description of Event or Problem

THE CUSTOMER REPORTED THAT THE MYOGLOBIN QUALITY CONTROLS (QC) USING BIO-RAD 87810 HAD VALUES SHIFTING DOWN ON BOTH LEVELS, AND AFTER CALIBRATING, LEVEL 1 WAS OK AND LEVEL 2 HAD HIGH VALUES WHILE USING THE ARCHITECT STAT MYOGLOBIN CALIBRATOR, LOT 166000. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2022 (NG/ML), L1= 32.8, L2= 115, AFTER CALIBRATING ON (B)(6) 2022 (NG/ML), L1 = 43.4, L2 = 161.9, BIO-RAD RANGE 87810 (NG/ML), L1 RANGE (33.4 - 49.9), L2 RANGE (91.8 - 150). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

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.