ALINITY I TOTAL B-HCG REAGENT KIT

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07P51-77 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P51-21 / 31, WITH 510K NUMBER K170317.

Description of Event or Problem

THE CUSTOMER REPORTED FALSE POSITIVE ALINITY I TOTAL B-HCG RESULT GENERATED ON A 30-YEAR-OLD FEMALE PATIENT WHEN PROCESSED ON THE ALINITY I PROCESSING MODULE. THE FOLLOWING INFORMATION WAS PROVIDED FOR SID (B)(6). (B)(6) 2026: INITIAL RESULT = 18.34 MIU/ML, PEG-TREATED SAMPLE AND SNIBE PLATFORM RESULTS WERE NEGATIVE. (B)(6) 2026; = 16.49 MIU/ML, LAST MENSTRUAL PERIOD WAS REPORTED AS (B)(6) 2026 AND PATIENT WAS HOSPITALIZED FOR ANEMIA AND AN INCARCERATED INTRAUTERINE DEVICE (IUD). (B)(6) 2026; = 13.10 MIU/ML & RECEIVED TRADITIONAL CHINESE MEDICINE-SUPPORTED ABORTION AND ORAL MIFEPRISTONE. (B)(6) 2026; = 13.42 MIU/ML. (B)(6) 2026: = 11.60 MIU/ML. (B)(6) 2026- = 15.75 MIU/ML & PRESCRIBED MIFEPRISTONE, TAKEN ORALLY FOR THREE DAYS. (B)(6) 2026: = 14.27 MIU/ML & PRESCRIBED MIFEPRISTONE, TAKEN ORALLY FOR THREE DAYS. (B)(6) 2026: = 18.65 MIU/ML. (B)(6) 2026: = 17.46 MIU/ML & PRESCRIBED MIFEPRISTONE, TAKEN ORALLY FOR THREE DAYS. (B)(6) 2026: = 21.06 MIU/ML. (B)(6) 2026: = 18.73 MIU/ML, PATIENT REPORTED AMENORRHEA FOR TWO MONTHS AND INTERMITTENT BLEEDING FOR MORE THAN ONE MONTH & HOSPITALIZED AGAIN FOR AN INCARCERATED IUD. (B)(6) 2026: = 13.66 MIU/ML, RECEIVED 64 MG INTRAMUSCULAR METHOTREXATE FOR PRESUMED EMBRYO TERMINATION. (B)(6) 2026: = 17.34 MIU/ML. (B)(6) 2026: PATIENT UNDERWENT HYSTEROSCOPIC REMOVAL OF THE INCARCERATED IUD AND DIAGNOSTIC DILATION AND CURETTAGE (D&C). THE ALINITY I TOTAL B-HCG PACKAGE INSERT REFERENCE RANGES ARE: </= 5.00 MIU/ML REPORTED AS NEGATIVE, > 5.00 AND < 25.00 MIU/ML REPORTED WITH CONCENTRATIONS ONLY (GRAYZONE), >/= 25.00 MIU/ML REPORTED AS POSITIVE. THE HYSTEROSCOPIC REMOVAL OF THE INCARCERATED IUD AND DIAGNOSTIC D&C DELAYED BECAUSE OF THE FALSELY ELEVATED B-HCG RESULTS. NO FURTHER IMPACT TO PATIENT MANAGEMENT WAS REPORTED.