MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. ALERE HCG COMBO CASSETTE; VISUAL, PREGNANCY HCG, PRESCRIPTION USE

Model Number FHC-A202

Device Problem False Positive Result (1227)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/14/2023

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: very low levels of hcg (less than 50 miu/ml) are present in serum and 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 serum or 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 serum or urine specimen 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 customer did not elect to return the product for investigation.

Event Description

The customer reported faint false positive results when testing patient urine samples with the alere hcg combo cassette.The customer reported a total of five false positive results between lot 0000641755 (this report) and lot 0000624450.The patients were being test prior to administration of birth control.The patients were sent for further testing by an unspecified method and received negative results.The procedures were delayed until the additional testing was performed.No adverse outcomes were reported.See mdr 2027969-2023-00091 for lot 0000624450.

• Brand Name: ALERE HCG COMBO CASSETTE
• 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: 17900657
• MDR Text Key: 325466340
• Report Number: 2027969-2023-00092
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K062361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/09/2023

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
• Device Operator: Health Professional
• Device Model Number: FHC-A202
• Device Catalogue Number: 92215
• Device Lot Number: 0000641755
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/19/2023
• Initial Date FDA Received: 10/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2022
• 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