ALINITY C LACTATE DEHYDROGENASE REAGENT KIT

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THERE WAS NO ADDITIONAL PATIENT INFORMATION PROVIDED BY THE CUSTOMER DUE TO PRIVACY ISSUES.

Description of Event or Problem

THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY C LACTATE DEHYDROGENASE (LDH) RESULTS ON ONE PATIENT. THE RESULTS PROVIDED WERE: ON (B)(6) 2021 SID (B)(6) INITIAL LDH = 247U/L (REFERENCE RANGE 125-220U/L)/ RETEST ONE HOUR LATER = 153U/L AND 140U/L. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

Additional Manufacturer Narrative

AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE WAS CHANGED FROM ALINITY C LACTATE DEHYDROGENASE REAGENT KIT, LIST NUMBER 07P74-20, AND MANUFACTURING SITE ABBOTT GMBH, MAX-PLANCK-RING 2, WIESBADEN, GERMANY, 65205 IN SECTION D OF THIS REPORT TO ALINITY C PROCESSING MODULE, LIST NUMBER 03R67-01, AND MANUFACTURING SITE OF ABBOTT GMBH, MAX-PLANCK-RING 2, WIESBADEN, GERMANY, 65205. MDR NUMBER 3002809144-2021-00114-00 HAS BEEN SUBMITTED AND ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER THAT MDR NUMBER.AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE WAS CHANGED FROM ALINITY C LACTATE DEHYDROGENASE REAGENT KIT, LIST NUMBER 07P74-20, AND MANUFACTURING SITE ABBOTT GMBH, MAX-PLANCK-RING 2, WIESBADEN, GERMANY, 65205 IN SECTION D OF THIS REPORT TO ALINITY C PROCESSING MODULE, LIST NUMBER 03R67-01, AND MANUFACTURING SITE OF ABBOTT GMBH, MAX-PLANCK-RING 2, WIESBADEN, GERMANY, 65205. MDR NUMBER 3002809144-2021-00114-00 HAS BEEN SUBMITTED AND ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER THAT MDR NUMBER.