Description of Event or Problem · 0
ON 17TH MAR 2023, PHASE SCIENTIFIC INTERNATIONAL LTD RECEIVED THE NOTIFICATION FROM FDA ABOUT A MEDWATCH REPORTING ON FALSE NEGATIVE COVID19 RAT RESULT (SEE MDR REPORT# MW5115749). A CUSTOMER, WHO DID NOT DISCLOSE PERSONAL INFORMATION, REPORTED THAT HE FOUND 3 INDICAID COVID 19 RAT TESTS SHOWING NEGATIVE RESULT. HOWEVER, THE CUSTOMER WAS CONFIRMED COVID POSITIVE ON THE SAME DAY IN THE DOCTOR APPOINTMENT. THE NEXT TWO DAYS, THE CUSTOMER CONTINUED GETTING NEGATIVE RESULT FROM INDICAID COVID RAT WHILE POSITIVE THE OTHER BRAND RAT SHOWED POSITIVE IN THE TEST. THERE IS NO PRODUCT LOT # OR CONTACT INFORMATION BEING PROVIDED IN THE MEDWATCH FORM PROVIDED. THERE IS NO HOSPITALIZATION, SEVERE INJURY OR DEATH REPORTED. THE DATE OF OCCURRENCE OF THE ISSUE IS ON (B)(6) 2023. THE DATE OF CUSTOMER REPORTING ON 21ST FEB 2023. PHASE SCIENTIFIC INTERNATIONAL LTD RECEIVED THE REPORT ON 17TH MAR 2023. THERE ARE 3 MORE REPORT (MDR REPORT# MW5115746, MDR REPORT# MW5115747, MDR REPORT# MW5115748) ALL PERTAINING TO THIS SAME COMPAINT. THIS MANUFACTURER MDR REPORT COVERS 4 REPORT FROM THE SAME CUSTOMER ON THE SAME COMPLAINT.