MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. HENRY SCHEIN HCG URINE CASSETTE; VISUAL, PREGNANCY HCG, PRESCRIPTION USE

Model Number	FHC-102
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation conclusion: an investigation was performed on retention product from the reported lot number.Retention devices were tested with cut-off standards (25 miu/ml) and high positive standards (204.6u/ml, 231.4iu/ml, and 245.4iu/ml).Results were read at 3 minutes and all devices yielded expected positive results.No false negatives 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 product.Complaints are tracked and trended on a monthly basis.Per the package insert: - very dilute urine specimens, as indicated by a low specific gravity, may not contain representative levels of hcg.If pregnancy is still suspected, a first morning urine specimen should be collected 48 hours later and tested.- false negative results may occur when the levels of hcg are below the sensitivity level of the test.When pregnancy is still suspected, a first morning urine specimen should be collected 48 hours later and tested.- this test reliably detects intact hcg up to 500,000miu/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.
Event or Problem Description
The customer reported receiving false negative hcg results while using the henry schein one step hcg urine cassettes.The customer indicating control failures were observed during qc testing, as a result, the customer decided to test the urine of a known pregnant patient as a further check for device performance.The patient urine sample was tested, the results were read at 3 minutes and a negative hcg result was observed.Although requested, there is no indication that the sample tested was intended for patient treatment.No adverse events were reported.No further information was provided.

• Brand Name: HENRY SCHEIN HCG URINE CASSETTE
• 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: 21153120
• Report Number: 2027969-2025-00012
• Device Sequence Number: 15853694
• Product Code: JHI
• UDI-Device Identifier: 10304040024116
• UDI-Public: (01)10304040024116(17)260410(10)0000859672
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K993317
• 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: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 01/14/2025

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: 04/10/2026
• Device Model Number: FHC-102
• Device Catalogue Number: 9004074
• Device Lot Number: 0000859672
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/24/2024
• Initial Report FDA Received Date: 01/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/11/2024
• 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 Sex: Female