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

Model Number FHC-102

Device Problem False Positive Result (1227)

Patient Problem Distress (2329)

Event Date 04/14/2023

Event Type  malfunction  

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-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: the hcg one step pregnancy test device (urine) is a preliminary qualitative test, therefore, neither the quantitative value nor the rate of increase in hcg can be determined by this test.Very low levels of hcg (less than 50 miu/ml) are present in urine specimens 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.This test may produce false positive results.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.H3 other text : the event was reported by the therapeutic goods administration of australia and no contact information was provided for the customer.

Event Description

The therapeutic goods administration of australia notified alere san diego of a complaint involving the hcg one step pregnancy test device.A patient urine sample was tested with the hcg one step pregnancy test device prior to removal of an expired intrauterine device.The hcg one step pregnancy test device produced a faint positive result.The test was repeated twice, each time with a faint positive result.Serum beta-hcg testing and a pelvic ultrasound were performed, and the patient was determined not to be pregnant.The event was reported to have temporarily exacerbated an underlying anxiety disorder.No other adverse outcomes were reported.The tga did not provide any contact information for the customer so it was not possible to obtain further information.

• Brand Name: HCG ONE STEP PREGNANCY TEST DEVICE
• Type of Device: 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: 17056387
• MDR Text Key: 316695879
• Report Number: 2027969-2023-00049
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K993317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FHC-102
• Device Catalogue Number: FHC-102
• Device Lot Number: 0000613121
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female