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

Model Number FHC-102

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 05/05/2023

Event Type  malfunction  

Event Description

The distributor reported that the one step+ hcg urine cassette test is not giving accurate results, and is taking too long.The customer did not specify whether the reported inaccurate results occurred on patient or control samples, and did not elaborate on the allegation that the test is taking too long.Three attempts have been made to obtain clarification, however the customer had been unresponsive.No adverse events were reported.

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.Retained devices were also tested with qc cut-off controls (25 miu/ml).The results were read at 3 minutes and all devices yielded the expected positive results.No false 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 dilute urine specimens, as indicated by a low specific gravity, may not contain representative levels of hcg.If pregnancy is still suspected, a first morning urine specimen should be collected 48 hours later and tested.False negative results may occur when the levels of hcg are below the sensitivity level of the test.When pregnancy is still suspected, a first morning urine specimen should be collected 48 hours later and tested.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.This test reliably detects intact hcg up to 500,000 miu/ml.It does not reliably detect hcg degradation products, including free-beta hcg and beta core fragments.Quantitative assays used to detect hcg may detect hcg degradation products and therefore may disagree with the results of this rapid test.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 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 indicated that product was available for return, however no product has been received and the customer has been unresponsive.

Manufacturer Narrative

Investigation conclusion: retained and returned devices from the reported lot number were tested with qc cut-off standards (25 miu/ml).The results were read at 3 minutes and all devices yielded the expected positive results.No false negative results were observed during in-house testing.Retained and returned devices from the reported lot numbers were also tested with hcg-negative clinical urine samples.The results were read at 3 and 4 minutes.All devices showed expected negative results.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 and returned products.Complaints are tracked and trended on a monthly basis.Per the package insert: very dilute urine specimens, as indicated by a low specific gravity, may not contain representative levels of hcg.If pregnancy is still suspected, a first morning urine specimen should be collected 48 hours later and tested.False negative results may occur when the levels of hcg are below the sensitivity level of the test.When pregnancy is still suspected, a first morning urine specimen should be collected 48 hours later and tested.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 weekly positive should be confirmed by retesting with a first morning urine specimen collected 48 hours later.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.D9 and h3 updated to reflect receipt of returned product.H6 and h10 investigation conclusion updated to document return testing.

Event Description

The distributor reported that the one step hcg urine cassette test is not giving accurate results, and is taking too long.The customer did not specify whether the reported inaccurate results occurred on patient or control samples, and did not elaborate on the allegation that the test is taking too long.Three attempts have been made to obtain clarification, however the customer had been unresponsive.No adverse events were reported.

• Brand Name: ONE STEP+ HCG URINE CASSETTE TEST
• 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: 17044446
• MDR Text Key: 316695919
• Report Number: 2027969-2023-00048
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 10304040024109
• UDI-Public: (01)10304040024109(17)240731(10)0000603856
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/17/2023

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-102
• Device Catalogue Number: 9004073
• Device Lot Number: 0000603856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/08/2023
• Initial Date FDA Received: 06/01/2023
• Supplement Dates Manufacturer Received: 10/17/2023
• Supplement Dates FDA Received: 10/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2022
• 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