CONSULT HCG TEST
Report
- Report Number
- 2027969-2025-00057
- Event Type
- Malfunction
- Date Received
- March 4, 2025
- Date of Event
- February 16, 2025
- Report Date
- June 19, 2025
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- JHI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
RESULTS PENDING COMPLETION OF THE INVESTIGATION. G4: PMA/510(K) #: THE PMA/510(K) FOR LN: 0000818406 IS K993203. THE PMA/510(K) FOR LN: 0000879966 IS K062361. D4: MODEL#: MODEL NUMBER FOR LN: 0000818406 IS FHC-101. MODEL NUMBER FOR LN: 0000879966 IS FHC-A102. D4: CATALOG#: CATALOG NUMBER FOR LN: 0000818406 IS 5000. CATALOG NUMBER FOR LN: 0000879966 IS 5001. D4: EXPIRATION DATE: THE EXPIRATION DATE FOR LN: 0000818406 IS 3DEC2025. THE EXPIRATION DATE FOR LN: 0000879966 IS 4JUN2026. D4: PRIMARY UDI NUMBER: THE UDI FOR LN: 0000818406 IS (B)(4). THE UDI FOR 0000879966 IS (B)(4). H4: DEVICE MFG DATE THE MANUFACTURING DATE FOR LN: 0000818406 IS 5DEC2023. THE MANUFACTURING DATE FOR LN: 0000879966 IS 5JUN2024.
G4: PMA/510(K)#: THE PMA/510(K) FOR LN: 0000818406 IS K993203. THE PMA/510(K) FOR LN: 0000879966 IS K062361. D4: MODEL#: MODEL NUMBER FOR LN: 0000818406 IS FHC-101. MODEL NUMBER FOR LN: 0000879966 IS FHC-A102. D4: CATALOG#: CATALOG NUMBER FOR LN: 0000818406 IS 5000. CATALOG NUMBER FOR LN: 0000879966 IS 5001. D4: EXPIRATION DATE: THE EXPIRATION DATE FOR LN: 0000818406 IS 3DEC2025. THE EXPIRATION DATE FOR LN: 0000879966 IS 4JUN2026. D4: PRIMARY UDI NUMBER: THE UDI FOR LN: 0000818406 IS (B)(4). THE UDI FOR 0000879966 IS (B)(4). H4: DEVICE MFG DATE THE MANUFACTURING DATE FOR LN: 0000818406 IS 5DEC2023. THE MANUFACTURING DATE FOR LN: 0000879966 IS 5JUN2024. H2, H3, H6 AND H11 UPDATED TO INCLUDE RETURN TESTING. INVESTIGATION CONCLUSION (LOT NUMBER: 0000818406): AN INVESTIGATION WAS PERFORMED ON RETENTION AND RETURN PRODUCTS FROM THE REPORTED LOT NUMBER. RETENTION AND RETURNED DEVICES WERE TESTED WITH CLINICAL NEGATIVE URINE SAMPLES, CUT-OFF STANDARDS (25 MIU/ML), AND HIGH POSITIVE STANDARDS (201.1IU/ML, 204.6IU/ML, AND 245.4IU/ML FOR RETENTION TESTING AND 201.1IU/ML AND 223.3IU/ML FOR RETURN TESTING). RESULTS WERE READ AT 3 AND 4 MINUTES FOR DEVICES TESTED WITH NEGATIVE SAMPLES. ALL DEVICES TESTED WITH CLINICALLY NEGATIVE URINE SAMPLES YIELDED NEGATIVE RESULTS. RESULTS WERE READ 3 MINUTES FOR DEVICES TESTED WITH CUT-OFF AND HIGH POSITIVE STANDARD SAMPLES. ALL DEVICES TESTED WITH CUT-OFF AND POSITIVE SAMPLES YIELDED POSITIVE RESULTS. NO FALSE POSITIVE OR NEGATIVE RESULTS WERE OBSERVED DURING IN-HOUSE TESTING. THE CASE DETAILS WERE REVIEWED ALONG WITH THE COMPLAINT HISTORY FOR THE REPORTED ISSUE AND NO INDICATIONS OF A SYSTEMIC ISSUE WERE IDENTIFIED. MANUFACTURING BATCH RECORD REVIEW DID NOT UNCOVER ANY ABNORMALITIES AND FOUND THAT THE LOT MET QUALITY CONTROL SPECIFICATIONS. REVIEW OF THE RISK MANAGEMENT REPORT FOR THIS PRODUCT FOUND THAT THE REPORTED ISSUE IS WITHIN THE RISK PROFILE FOR THIS DEVICE; NO NEW HAZARD HAS BEEN IDENTIFIED. A ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION AS THE REPORTED ISSUE WAS NOT REPLICATED DURING TESTING OF RETENTION OR RETURN PRODUCT. COMPLAINTS ARE TRACKED AND TRENDED ON A MONTHLY BASIS. PER THE PACKAGE INSERT: VERY LOW LEVELS OF HCG (LESS THAN 50 MIU/ML) ARE PRESENT IN URINE SPECIMEN SHORTLY AFTER IMPLANTATION. HOWEVER, BECAUSE A SIGNIFICANT NUMBER OF FIRST TRIMESTER PREGNANCIES TERMINATE FOR NATURAL REASONS, A TEST RESULT THAT IS WEAKLY POSITIVE SHOULD BE CONFIRMED BY RETESTING WITH A FIRST MORNING URINE SPECIMEN COLLECTED 48 HOURS LATER. A NUMBER OF CONDITIONS OTHER THAN PREGNANCY, INCLUDING TROPHOBLASTIC DISEASE AND CERTAIN NON-TROPHOBLASTIC NEOPLASMS INCLUDING TESTICULAR TUMORS, PROSTATE CANCER, BREAST CANCER, AND LUNG CANCER, CAUSE ELEVATED LEVELS OF HCG. THEREFORE, THE PRESENCE OF HCG IN URINE SPECIMEN SHOULD NOT BE USED TO DIAGNOSE PREGNANCY UNLESS THESE CONDITIONS HAVE BEEN RULED OUT. THIS TEST PROVIDES A PRESUMPTIVE DIAGNOSIS FOR PREGNANCY. A CONFIRMED PREGNANCY DIAGNOSIS SHOULD ONLY BE MADE BY A PHYSICIAN AFTER ALL CLINICAL AND LABORATORY FINDINGS HAVE BEEN EVALUATED. INVESTIGATION CONCLUSION (LOT NUMBER: 0000879966): AN INVESTIGATION WAS PERFORMED ON RETENTION AND RETURN PRODUCTS FROM THE REPORTED LOT NUMBER. RETENTION AND RETURNED DEVICES WERE TESTED WITH CLINICAL NEGATIVE URINE SAMPLES, CUT-OFF STANDARDS (20 MIU/ML), AND HIGH POSITIVE STANDARDS (201.1IU/ML, 204.6IU/ML, AND 245.4IU/ML FOR RETENTION TESTING AND 201.1IU/ML AND 223.3IU/ML FOR RETURN TESTING). RESULTS WERE READ AT 3 AND 4 MINUTES FOR DEVICES TESTED WITH NEGATIVE SAMPLES. ALL DEVICES TESTED WITH CLINICALLY NEGATIVE URINE SAMPLES YIELDED NEGATIVE RESULTS. RESULTS WERE READ 3 MINUTES FOR DEVICES TESTED WITH CUT-OFF AND HIGH POSITIVE STANDARD SAMPLES. ALL DEVICES TESTED WITH CUT-OFF AND POSITIVE SAMPLES YIELDED POSITIVE RESULTS. NO FALSE POSITIVE OR NEGATIVE RESULTS WERE OBSERVED DURING IN-HOUSE TESTING. THE CASE DETAILS WERE REVIEWED ALONG WITH THE COMPLAINT HISTORY FOR THE REPORTED ISSUE AND NO INDICATIONS OF A SYSTEMIC ISSUE WERE IDENTIFIED. MANUFACTURING BATCH RECORD REVIEW DID NOT UNCOVER ANY ABNORMALITIES AND FOUND THAT THE LOT MET QUALITY CONTROL SPECIFICATIONS. REVIEW OF THE RISK MANAGEMENT REPORT FOR THIS PRODUCT FOUND THAT THE REPORTED ISSUE IS WITHIN THE RISK PROFILE FOR THIS DEVICE; NO NEW HAZARD HAS BEEN IDENTIFIED. A ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION AS THE REPORTED ISSUE WAS NOT REPLICATED DURING TESTING OF RETENTION OR RETURN PRODUCT. COMPLAINTS ARE TRACKED AND TRENDED ON A MONTHLY BASIS. PER THE PACKAGE INSERT: VERY LOW LEVELS OF HCG (LESS THAN 50 MIU/ML) ARE PRESENT IN URINE SPECIMEN SHORTLY AFTER IMPLANTATION. HOWEVER, BECAUSE A SIGNIFICANT NUMBER OF FIRST TRIMESTER PREGNANCIES TERMINATE FOR NATURAL REASONS, A TEST RESULT THAT IS WEAKLY POSITIVE SHOULD BE CONFIRMED BY RETESTING WITH A FIRST MORNING URINE SPECIMEN COLLECTED 48 HOURS LATER. A NUMBER OF CONDITIONS OTHER THAN PREGNANCY, INCLUDING TROPHOBLASTIC DISEASE AND CERTAIN NON-TROPHOBLASTIC NEOPLASMS INCLUDING TESTICULAR TUMORS, PROSTATE CANCER, BREAST CANCER, AND LUNG CANCER, CAUSE ELEVATED LEVELS OF HCG. THEREFORE, THE PRESENCE OF HCG IN URINE SPECIMEN SHOULD NOT BE USED TO DIAGNOSE PREGNANCY UNLESS THESE CONDITIONS HAVE BEEN RULED OUT. THIS TEST PROVIDES A PRESUMPTIVE DIAGNOSIS FOR PREGNANCY. A CONFIRMED PREGNANCY DIAGNOSIS SHOULD ONLY BE MADE BY A PHYSICIAN AFTER ALL CLINICAL AND LABORATORY FINDINGS HAVE BEEN EVALUATED.
THE CUSTOMER REPORTED RECEIVING DISCREPANT RESULTS FOR 2 DIFFERENT INDIVIDUALS WHEN USING CONSULT HCG DIPSTICK TESTS AND CONSULT HCG URINE CASSETTES. THE CUSTOMER REPORTED THE FIRST PATIENT PRESENTED FOR AN UNSPECIFIED REASON. A FRESH URINE SAMPLE WAS PROVIDED WHICH YIELDED A FAINT POSITIVE HCG RESULT WITH THE CONSULT DIPSTICK TEST AND A NEGATIVE HCG RESULT WITH THE CONSULT CASSETTE TEST. AN ADDITIONAL CONSULT HCG DIPSTICK TEST WAS PERFORMED WHICH ALSO YIELDED A FAINT POSITIVE RESULT. THE CUSTOMER WAS UNSURE WHICH DEVICE WAS ACCURATE AND DECIDED TO TEST A COLLEAGUE'S SAMPLE AS A QUALITY CONTROL CHECK. NO ADVERSE EVENT WAS REPORTED. SEE MDR 2027969-2025-00058 FOR THE RESULTS OF THE QUALITY CONTROL CHECK WITH THE COLLEAGUE. PLEASE NOTE: ONLY THE GENERIC DEVICE INFORMATION SHARED BETWEEN THE TWO DEVICES WILL BE PROVIDED IN THE SUSPECT MEDICAL DEVICE TABS AS THE CUSTOMER WAS UNABLE TO INDICATE WHICH DEVICE YIELDED A FALSE RESULT. SEE ADDITIONAL NOTES IN H11 FOR SPECIFIC DEVICE INFORMATION.
THE CUSTOMER REPORTED RECEIVING DISCREPANT RESULTS FOR 2 DIFFERENT INDIVIDUALS WHEN USING CONSULT HCG DIPSTICK TESTS AND CONSULT HCG URINE CASSETTES. THE CUSTOMER REPORTED THE FIRST PATIENT PRESENTED FOR AN UNSPECIFIED REASON. A FRESH URINE SAMPLE WAS PROVIDED WHICH YIELDED A FAINT POSITIVE HCG RESULT WITH THE CONSULT DIPSTICK TEST AND A NEGATIVE HCG RESULT WITH THE CONSULT CASSETTE TEST. AN ADDITIONAL CONSULT HCG DIPSTICK TEST WAS PERFORMED WHICH ALSO YIELDED A FAINT POSITIVE RESULT. THE CUSTOMER WAS UNSURE WHICH DEVICE WAS ACCURATE AND DECIDED TO TEST A COLLEAGUE'S SAMPLE AS A QUALITY CONTROL CHECK. NO ADVERSE EVENT WAS REPORTED. SEE MDR 2027969-2025-00058 FOR THE RESULTS OF THE QUALITY CONTROL CHECK WITH THE COLLEAGUE. PLEASE NOTE: ONLY THE GENERIC DEVICE INFORMATION SHARED BETWEEN THE TWO DEVICES WILL BE PROVIDED IN THE SUSPECT MEDICAL DEVICE TABS AS THE CUSTOMER WAS UNABLE TO INDICATE WHICH DEVICE YIELDED A FALSE RESULT. SEE ADDITIONAL NOTES IN H11 FOR SPECIFIC DEVICE INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2276443 | CONSULT HCG TEST | VISUAL, PREGNANCY HCG, PRESCRIPTION USE | JHI | ALERE SAN DIEGO, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 21 YR | Female |