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
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.
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-conformance's 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.However, complaint details indicate that urinalysis of the patient samples showed elevated levels of blood, leukocytes, urobilinogen, protein, ketones, and ascorbic acid.While hemoglobin and ascorbic acid did not interfere with the assay when tested at concentrations of 1,000 mg/dl and 20 mg/dl, respectively, the other substances have not been evaluated for interference with this assay.Please see the interfering substances section of the package insert for additional information.Complaints are tracked and trended on a monthly basis.Per the package insert: very low levels of hcg (less than 50 miu/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 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.

• 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
• Manufacturer Contact: monika burrell ; 9942 mesa rim rd; san diego, CA 92121 ; 8588052506
• MDR Report Key: 20164082
• Report Number: 2027969-2024-00161
• Device Sequence Number: 12603876
• 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
• 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,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/06/2024

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2024
• Initial Report FDA Received Date: 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/17/2023
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 24 YR
• Patient Sex: Female
• Patient Weight: 82 KG
• Patient Ethnicity: Hispanic