MAUDE Adverse Event Report: ALERE SAN DIEGO CONSULT HCG URINE CASSETTE 5001 25T; HCG PREGNANCY TEST

Model Number FHC-A102

Device Problem False Negative Result (1225)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Results pending completion of the investigation.

Event Description

The distributer reported that a women's health facility was having false negative results on the hcg urine cassette.Information regarding patient information and outcome, the circumstances surrounding the event, and product identifiers were requested but the customer was unwilling to provide the information.

Manufacturer Narrative

Additional information: d10: device availability-changed from yes to no.Investigation conclusion: the case details were reviewed along with the complaint history for the reported issue and no indications of a systemic issue were identified.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.Retain testing and manufacturing record review could not be performed as a lot number could not be obtained.Only limited information regarding technique, storage, and handling could be provided.A root cause could not be determined due to insufficient information.Per the package insert, false negative results may occur when the levels of hcg are below the sensitivity level of the test.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.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: CONSULT HCG URINE CASSETTE 5001 25T
• Type of Device: HCG PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO; 9995 summers ridge rd; san diego CA 92121
• MDR Report Key: 9404667
• MDR Text Key: 188844122
• Report Number: 2027969-2019-00606
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• PMA/PMN Number: K062361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 01/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FHC-A102
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1