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	02/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported receiving false negative hcg results with four boxes of henry schein hcg dipstick urine tests.Technical services attempted to clarify the total number of false negative results obtained and number of patients involved, however, they were unresponsive.The customer indicated only 1 patient was impacted and testing took place on (b)(6)2025, however limited information was provided.The customer indicated the patient was tested due to amenorrhea with a mirena iud implanted.During the troubleshooting process, the customer reported the control line was not present and the background was not clear when the results were interpreted.Additionally, a timer was not used.According to the package insert, negative: one red line appears in the control region (c).No apparent red or pink line appears in the test region (t).Invalid: control line fails to appear.Additionally, read the result at 3-4 minutes.Do not interpret results after the appropriate read time.It is important that the background is clear before the result is read.The customer indicated confirmatory testing was performed on (b)(6) 2025 using a fresh urine sample, a device from a different lot, and a positive hcg result was obtained.It was reported that treatment was provided, however it is unclear if the treatment was emergent or nonemergent.Labs and an ultrasound were performed; however, specifics were not provided.The patient was diagnosed as 22 weeks pregnant.Although requested, no further information was provided.Please note, although deviations were noted and there appears to be no malfunction; this is conservatively being reported as a serious injury as there is the potential for harm to the patient and/or fetus due to the presence of an iud in place.Additionally, it was reported that treatment was given as a result of the negative result, no further details were provided.
Additional Manufacturer Narrative
N/a.

• 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
• MDR Report Key: 21684070
• Report Number: 3006984151-2025-00003
• Device Sequence Number: 8850016
• Product Code: JHI
• UDI-Device Identifier: 10304040024093
• UDI-Public: (01)10304040024093(17)260303(10)0000849001
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 03/24/2025
• Report Date (Section F): 03/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/26/2025
• Device Age: 11 MO
• Date Report to Manufacturer: 02/26/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/24/2025
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 32 YR
• Patient Sex: Female
• Patient Weight: 103 KG
• Patient Race: White
• Date Report Sent to FDA: 03/24/2025