D
Patient 1
ON INITIAL TESTING ((B)(6) 2012), THE CUSTOMER OBSERVED A SUSCEPTIBLE IMIPENEM RESULT ON B1025-112 (LOT NUMBER UNAVAILABLE) SURVEY D-12 K. PNEUMONIAE. THE CORRECT RESULT FOR IMIPENEM WAS INTERMEDIATE OR RESISTANT. ON REPEAT TESTING ON (B)(6) 2012 USING B1025-112, LOT 2013-06-08, SUSCEPTIBLE IMIPENEM RESULTS WERE AGAIN OBSERVED FOR THE WALKAWAY READ. WHEN THE PANELS WERE VISUALLY CHECKED, THERE WAS GROWTH IN THE IMIPENEM WELLS (IMIPENEM WOULD BE CALLED RESISTANT BY MANUAL READ). SIEMENS MICROSCAN CONDUCTED A FIELD CORRECTION, INTERNAL NUMBER MSSW 13-02 (FDA NUMBER HAS NOT BEEN ASSIGNED) ON 08/21/2013 FOR FALSE SUSCEPTIBLE IMIPENEM AND MEROPENEM WITH SYNERGIES PLUS NEGATIVE PANELS. THE CUSTOMER LETTER STATED THAT DUE TO FALSE SUSCEPTIBLE RESULTS WITH IMIPENEM AND MEROPENEM SHOULD NOT BE REPORTED FOR SUSCEPTIBLE OR INTERMEDIATE IMIPENEM OR MEROPENEM ON MICROSCAN SYNERGIES PLUS GRAM NEGATIVE PANELS. AS PART OF THE FIELD ACTION, COMPLAINTS WERE REVIEWED AND IT WAS DETERMINED A MDR WAS NEEDED FOR THIS CUSTOMER COMPLAINT.