BINAXNOW G6PD KIT

Additional Manufacturer Narrative

DATE OF EVENT PROVIDED IN SECTION B3 IS AN APPROXIMATION, WAS NOT PROVIDED BY CONSUMER. D4 UDI: (B)(4). TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 181228 WITH INTERNAL POSITIVE QUALITY CONTROL SAMPLES AND NEGATIVE QUALITY CONTROL SAMPLES. ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. NO FALSE NEGATIVE(NORMAL) RESULTS WERE OBSERVED, AND THE CUSTOMERS COMPLAINT WAS NOT REPLICATED. ADDITIONALLY, THE MANUFACTURING RECORDS AND QUALITY CONTROL RELEASE TESTING WAS REVIEWED FOR TEST KIT PART NUMBER 780-000 / LOT 195040, TEST BASE PART NUMBER 780-430 / LOT 194666. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 195040 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE H3 OTHER TEXT : SINGLE-USE, DEVICE DISCARDED.

Description of Event or Problem

THE CUSTOMER REPORTED FOUR (4) FALSE NEGATIVE RESULTS WITH THE BINAXNOW G6PD KIT PERFORMED ON UNKNOWN DATES. THIS MFR. REPORT ADDRESSES TEST THREE (3) OF FOUR (4). CONFIRMATION ELISA TESTING WAS PERFORMED ON AN UNKNOWN DATE, WHICH GENERATED A POSITIVE RESULT. REPEAT TESTING WAS PERFORMED THRICE ON THE SAME SAMPLE AND ONCE ON A NEW SAMPLE AT AN INTERVAL OF 2 WEEKS, WHICH EACH GENERATED A NEGATIVE RESULT. THE CUSTOMER REPORTED THERE WAS AN IMPACT IN THE PATIENT'S TREATMENT; A DRUG CONTRAINDICATED FOR G6PD DEFICIENCY WAS PRESCRIBED AND TAKEN. THE NAME OF THE DRUG WAS NOT PROVIDED. THE CUSTOMER CONFIRMED THERE WAS DEATH OR NO SERIOUS INJURY BASED ON THE TEST RESULTS. ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT INFORMATION, INCLUDING OUTCOME, WAS PROVIDED.