MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. MEDLINE HCG PREGNANCY TEST STRIP (URINE); VISUAL, PREGNANCY HCG, PRESCRIPTION USE

Model Number	FHC-101
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported receiving false positive hcg results for 2 patients while using medline hcg urine dipsticks.The customer reported the second patient presented for "on and off bleeding" after undergoing a medical abortion procedure on an unspecified date.The patient provided a urine sample which appeared bloody, however no precipitates were observed.The sample was tested and yielded a positive hcg result.An additional test was performed using a device from the same lot and an additional hcg result was obtained.A confirmatory stat beta hcg test was performed which yielded a negative result.No adverse health outcomes were reported.See emdr 2027969-2025-00195 for the first patient.
Additional Manufacturer Narrative
Investigation conclusion: retained devices from the reported lot number were tested with hcg-negative clinical urine samples.The results were read at 3 and 4 minutes and all devices yielded valid negative results.No false positive 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 relevant non-conformances 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 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.- this test reliably detects intact hcg up to 500,000 miu/ml.It does not reliably detect hcg degradation products, including free-beta hcg and beta core fragments.Quantitative assays used to detect hcg may detect hcg degradation products and therefore may disagree with the results of this rapid test.- 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 hcg.Therefore, the presence of hcg in urine should not be used to diagnose pregnancy unless these conditions have been ruled out.- thie 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.
Event or Problem Description
The customer reported receiving false positive hcg results for 2 patients while using medline hcg urine dipsticks.The customer reported the second patient presented for "on and off bleeding" after undergoing a medical abortion procedure on an unspecified date.The patient provided a urine sample which appeared bloody, however no precipitates were observed.The sample was tested and yielded a positive hcg result.An additional test was performed using a device from the same lot and an additional hcg result was obtained.A confirmatory stat beta hcg test was performed which yielded a negative result.No adverse health outcomes were reported.See emdr 2027969-2025-00195 for the first patient.
Additional Manufacturer Narrative
D9 - device available for evaluation: was updated from "no" to "yes" d9 - date returned to mfg: was updated from blank to "9/19/2025" d9 - date returned to mfg null: was updated from "na" to blank.H3 - device evaluated by mfg?: was updated from "no" to "yes" h6 - adverse event problem and h11 were updated to include return investigation findings.Investigation conclusion: retained and returned devices from the reported lot number were tested with hcg-negative clinical urine samples.The results were read at 3 and 4 minutes and all devices yielded valid negative results.No false positive 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 relevant non-conformances 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 returned 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.This test reliably detects intact hcg up to 500,000 miu/ml.It does not reliably detect hcg degradation products, including free-beta hcg and beta core fragments.Quantitative assays used to detect hcg may detect hcg degradation products and therefore may disagree with the results of this rapid test.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 hcg.Therefore, the presence of hcg in urine should not be used to diagnose pregnancy unless these conditions have been ruled out.Thie 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.

• Brand Name: MEDLINE HCG PREGNANCY TEST STRIP (URINE)
• Common Device Name: VISUAL, PREGNANCY HCG, PRESCRIPTION USE
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9942 mesa rim rd; san diego CA 92121
• Manufacturer Contact: monika burrell ; 9942 mesa rim rd; san diego, CA 92121 ; 8588052506
• MDR Report Key: 23067464
• Report Number: 2027969-2025-00196
• Device Sequence Number: 10044429
• Product Code: JHI
• UDI-Device Identifier: 10884389191873
• UDI-Public: (01)10884389191873(17)261104(10)0000934852
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K993203
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FHC-101
• Device Catalogue Number: MPH11025HCG
• Device Lot Number: 0000934852
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2025
• Supplement Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 20 YR
• Patient Sex: Female
• Patient Weight: 42 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian