BINAXNOW MALARIA 25T OUS

Description of Event or Problem

THE CUSTOMER REPORTED TWO (2) FALSE NEGATIVE RESULTS WITH THE BINAXNOW MALARIA TEST ON TWO (2) PATIENTS ON UNKNOWN DATES USING K3EDTA BLOOD IN 2.7ML MONOVETTES FROM SARSTEDT, WHICH WAS PREPARED IMMEDIATELY UPON RECEIPT. THIS IS REPORT ONE (1) OF TWO (2) THE CUSTOMER INDICATED THAT BOTH PATIENTS TESTED NEGATIVE FOR P. FALCIPARUM AND WERE SYMPTOMATIC. THE CUSTOMER REPORTED THAT NEW SAMPLES WERE TAKEN FROM THE PATIENTS AND MICROSCOPICALLY EXAMINED PER FACILITY PROTOCOL WHICH SHOWED A POSITIVE RESULT FOR P. FALCIPARUM. THERE WAS NO REPORT OF PATIENT IMPACT AS A RESULT. THE CUSTOMER ALSO REPORTED THAT THEY HAVE SEEN AN INCREASE IN THE HIGH-DOSE HOOK EFFECT IN THE P. FALCIPARUM BAND. NO ADDITIONAL INFORMATION WAS REPORTED.

Additional Manufacturer Narrative

G4: THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 660-000 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 665-025. CORRECTED DATA: D4, LOT NUMBER, PRIMARY UDI NUMBER TO INCLUDE PROCEEDING ZEROS ADDITIONAL INFORMATION THE CUSTOMER PROVIDED THE EVENT DATE ((B)(6) 2025) AND CONFIRMED THAT THERE WAS NO IMPACT TO THE PATIENT. SEE UPDATE TO SECTION B2-DATE OF EVENT AND H6, ANNEX E, F. INVESTIGATION SUMMARY: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 0000945458 WITH INTERNAL POSITIVE QUALITY CONTROL SAMPLES AND NEGATIVE QUALITY CONTROL SWABS. ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. ADDITIONALLY, THE MANUFACTURING RECORDS AND QUALITY CONTROL RELEASE TESTING WAS REVIEWED FOR TEST KIT PART NUMBER 660-000 LOT 0000945458 AND DEVICE PART NUMBER 665-430 LOT 925967. 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 0000945458 SHOWED THAT THE COMPLAINT RATE IS (B)(4). IN CONCLUSION, ABBOTT DIAGNOSTICS SCARBOROUGH DID NOT IDENTIFY A PRODUCT DEFICIENCY. THE RETENTION TESTING YIELDED EXPECTED RESULTS WHEN TESTING INTERNAL QUALITY CONTROL SAMPLES, THE BATCH HISTORY RECORD REVIEW REVEALED THAT THE PRODUCT MET ACCEPTANCE CRITERIA FOR RELEASE, AND REVIEW OF COMPLAINT TRENDS AGAINST THE KIT LOT FOR THE REPORTED ISSUES INDICATE THAT THE PRODUCT IS PERFORMING WITHIN EXPECTED CLAIMS IN THE CURRENT REVISION OF THE PACKAGE INSERT. ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE; HOWEVER, IT COULD HAVE BEEN RELATED TO THE SPECIFIC PATIENT SAMPLES.

Additional Manufacturer Narrative

G4: THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 660-000 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 665-025. THE INVESTIGATION IS ONGOING; A SUPPLEMENT REPORT WILL BE SUBMITTING UPON COMPLETION.

Description of Event or Problem

THE CUSTOMER REPORTED TWO (2) FALSE NEGATIVE RESULTS WITH THE BINAXNOW MALARIA TEST ON TWO (2) PATIENTS ON UNKNOWN DATES USING K3EDTA BLOOD IN 2.7ML MONOVETTES FROM SARSTEDT, WHICH WAS PREPARED IMMEDIATELY UPON RECEIPT. THIS IS REPORT ONE (1) OF TWO (2) THE CUSTOMER INDICATED THAT BOTH PATIENTS TESTED NEGATIVE FOR P. FALCIPARUM AND WERE SYMPTOMATIC. THE CUSTOMER REPORTED THAT NEW SAMPLES WERE TAKEN FROM THE PATIENTS AND MICROSCOPICALLY EXAMINED PER FACILITY PROTOCOL WHICH SHOWED A POSITIVE RESULT FOR P. FALCIPARUM. THERE WAS NO REPORT OF PATIENT IMPACT AS A RESULT. THE CUSTOMER ALSO REPORTED THAT THEY HAVE SEEN AN INCREASE IN THE HIGH-DOSE HOOK EFFECT IN THE P. FALCIPARUM BAND. NO ADDITIONAL INFORMATION WAS REPORTED.