MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. ONE STEP+ HCG URINE STRIP TEST; VISUAL, PREGNANCY HCG, PRESCRIPTION USE

Model Number	FHC-101
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
N/a.
Event or Problem Description
The customer reported a false positive result when testing a patient urine sample using the one step+ hcg urine strip test.The patient presented with abdominal pain and hematuria.The patient was sent to the emergency department for additional work-up, where it was determined that the patient was not pregnant.It was later stated that the patient had been hospitalized, however no additional details were provided.Attempts to obtain further information are ongoing.The customer reported a false positive result for an additional patient.See h10 for the related mdr number.

• Brand Name: ONE STEP+ HCG URINE STRIP TEST
• 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: 20219836
• Report Number: 3006984151-2024-00008
• Device Sequence Number: 7858244
• Product Code: JHI
• UDI-Device Identifier: 10304040024093
• UDI-Public: (01)10304040024093(17)251015(10)0000789150
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 09/14/2024
• Report Date (Section F): 09/14/2024

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: 10/15/2025
• Device Model Number: FHC-101
• Device Catalogue Number: 9004072
• Device Lot Number: 0000789150
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/14/2024
• Device Age: 10 MO
• Date Report to Manufacturer: 08/14/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/14/2024
• 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: Hospitalization
• Patient Age: 35 YR
• Patient Sex: Female
• Patient Weight: 109 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White
• Date Report Sent to FDA: 09/14/2024