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

Model Number	FHC-101
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3 - date of event: was not provided therefore 1mar2025 was selected.Results pending completion of the investigation.
Event or Problem Description
The distributor stated the customer reported "running negative results" on two lots of henry schein hcg dipstick urine tests.The customer returned 4 boxes of lot 0000849001 and 1 kit of lot 0000831257 to the distributor.It is unclear if the negative results were obtained with patient samples or controls, or the number of negative results obtained.Although requested, no further information was provided.No adverse events were reported.This event is conservatively being reported as a reportable malfunction.See mdr 2027969-2025-00081 for the reported issue on lot 0000831257.
Additional Manufacturer Narrative
B3 - date of event: was not provided therefore 1mar2025 was selected."h6 - adverse event problem" and "h11-additional mfg narrative" were updated to include the investigation findings.Investigation conclusion: retained devices from the reported lot number were tested with hcg-negative clinical urine and cut-off (25 miu/ml) samples.The results were read at 3 for devices tested using cut-off samples and positive results were obtained.The results were read at 3 and 4 minutes for devices tested using negative urine samples yielded negative 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 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 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 500,000 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.
Event or Problem Description
The distributor stated the customer reported "running negative results" on two lots of henry schein hcg dipstick urine tests.The customer returned 4 boxes of lot 0000849001 and 1 kit of lot 0000831257 to the distributor.It is unclear if the negative results were obtained with patient samples or controls, or the number of negative results obtained.Although requested, no further information was provided.No adverse events were reported.This event is conservatively being reported as a reportable malfunction.See mdr 2027969-2025-00081 for the reported issue on lot 0000831257.

• Brand Name: HENRY SCHEIN HCG DIPSTICK 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: 21755505
• Report Number: 2027969-2025-00080
• Device Sequence Number: 15512799
• Product Code: JHI
• UDI-Device Identifier: 10304040024093
• UDI-Public: (01)10304040024093(17)260303(10)0000849001
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2025

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: 03/03/2026
• Device Model Number: FHC-101
• Device Catalogue Number: 9004072
• Device Lot Number: 0000849001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2025
• Supplement Date Received by Manufacturer: 04/14/2025
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/04/2024
• 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