MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. CONSULT DIAGNOSTICS HCG URINE TESTS DIPSTICK; 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	12/27/2024
Type of Reportable Event	Malfunction
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 the expected 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 retained product.Complaints are tracked and trended on a monthly basis.Per the package insert: ¿ very low levels of hcg (less than 50 mlu/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.
Event or Problem Description
The customer reported false positive results when testing two patients with the consult diagnostics hcg urine tests dipstick.Patient (b)(6) was tested twice, both times with positive results.The patient's prescription was changed from suboxone (buprenorphine/naloxone) to buprenorphine due to the false positive results.The patient stated that it was impossible that she was pregnant and performed her own pregnancy test the following day with a negative result.The patient had not taken any of the new medication, and the prescription was changed back following the negative result.The customer confirmed that there was no negative impact due to the change in medication.See h10 for mdr number related to the other patient.

• Brand Name: CONSULT DIAGNOSTICS HCG URINE TESTS DIPSTICK
• 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: 21194231
• Report Number: 2027969-2025-00014
• Device Sequence Number: 18011304
• Product Code: JHI
• UDI-Device Identifier: 20612479202751
• UDI-Public: (01)20612479202751(17)250126(10)0000670362
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/20/2025

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 Expiration Date: 01/26/2025
• Device Model Number: FHC-101
• Device Catalogue Number: 5000
• Device Lot Number: 0000670362
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2025
• Initial Report FDA Received Date: 01/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/28/2023
• 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: 39 YR
• Patient Sex: Female
• Patient Weight: 226 LB
• Patient Race: White