DETERMINE HIV-1/2 AG/AB COMBO 25T

Additional Manufacturer Narrative

ABBOTT TECHNICAL SERVICES ADVISED THE CUSTOMER VIA EMAIL THAT CORD BLOOD IS NOT AN APPROPRIATE SAMPLE TYPE AND THAT THE KIT IS INTENDED FOR USE WITH PATIENTS 12 OR OLDER. THE CURRENT REVISION OF THE PACKAGE INSERT IN02732530 V 8.0 WAS REVIEWED AS RELATED TO THIS COMPLAINT. INTENDED USE: DETERMINE HIV-1/2 AG/AB COMBO IS NOT INTENDED FOR NEWBORN SCREENING OR FOR USE WITH CORD BLOOD SPECIMENS OR SPECIMENS FROM INDIVIDUALS LESS THAN 12 YEARS OF AGE. ABBOTT SCIENTIFIC AFFAIRS WAS CONSULTED ON USING CORD BLOOD/TESTING ON NEWBORN BABIES AND ADVISED THAT THE ANTIBODY TESTING IS NOT THE BEST FOR SCREENING SINCE ANTIBODIES CAN TRANSFER FROM THE MOTHER. SCIENTIFIC AFFAIRS RECOMMENDED USING MOLECULAR TESTING FOR THESE PATIENTS. DURING THE TIME OF THIS COMPLAINT AND AS PART OF AN INVESTIGATION INTO PRELIMINARY FALSE REACTIVE RESULTS, A FIELD PRODUCT CORRECTION IMPACTING SELECT LOTS OF DETERMINE¿ HIV-1/2 AG/AB COMBO WAS EXECUTED. ABBOTT CONFIRMED THE IMPACTED LOTS THAT WERE IDENTIFIED HAVE A HIGHER OCCURRENCE OF PRELIMINARY FALSE REACTIVE COMPLAINTS DUE TO A SUBCOMPONENT USED IN THE MANUFACTURE OF DETERMINE HIV-1/2 AG/AB COMBO. THE ISSUE HAS BEEN ISOLATED TO SPECIFIC LOTS OF THE SUBCOMPONENT THAT WERE USED TO MANUFACTURE THE IMPACTED KIT LOTS, HOWEVER THE KIT LOT NUMBER WAS NOT ABLE TO BE CONFIRMED FOR THIS INVESTIGATION. THE NECESSARY ACTIONS TO PREVENT RECURRENCE HAVE BEEN TAKEN, AND THE CORRECTION OF PRODUCT IN THE FIELD WAS CONDUCTED. THE INFORMATION TO ENABLE FURTHER INVESTIGATION, SUCH AS THE KIT'S LOT NUMBER, WAS NOT PROVIDED AND AN INVESTIGATION WAS NOT ABLE TO BE PERFORMED. NOTWITHSTANDING, COMPLAINTS AGAINST THESE TREND CODES ARE MONITORED TO IDENTIFY AND TRACK ANY OUT OF TREND / UNEXPECTED PERFORMANCE AT THE LOT AND PRODUCT FAMILY LEVEL.

Description of Event or Problem

THE CUSTOMER REPORTED TWO (2) FALSE POSITIVE RESULTS WITH THE DETERMINE HIV COMBO TEST ON AN UNKNOWN DATE FOR ONE (1) PATIENT. THIS IS REPORT TWO (2) OF TWO (2). THE CUSTOMER STATED THAT THE SAMPLE WAS CORD BLOOD FROM A NICU PATIENT WHICH WAS RUN TWICE WITH THE DETERMINE HIV COMBO AND BOTH PRESENTED POSITIVE RESULTS. CONFIRMATION TESTING (PLATFORM UNKNOWN) WAS PERFORMED ON AN UNKNOWN DATE WHICH PRESENTED NEGATIVE RESULTS. THE CUSTOMER REPORTED THAT THERE WAS NO IMPACT TO THE PATIENT AS A RESULT. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS RECEIVED.