MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. SURESTEP HCG URINE CASSETTE; PREGNANCY TEST

Model Number FHC-102

Device Problem False Negative Result (1225)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

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 batch record review could not be performed as a lot number could not be obtained.A root cause could not be determined based on the available information.As stated in the product 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.When pregnancy is still suspected, a first morning urine specimen should be collected 48 hours later and tested.A first morning urine specimen is preferred since it generally contains the highest concentration of hcg.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.

Event Description

Unspecified date: false negative result 1x on the surestep hcg urine cassette.Confirmatory testing on both the clearview home pregnancy test and the 1st response home pregnancy test provided positive results.Although further information was requested, no further information was provided.

• Brand Name: SURESTEP HCG URINE CASSETTE
• Type of Device: PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge rd.; san diego CA 92121
• Manufacturer Contact: monika burrell ; 9975 summers ridge rd.; san diego, CA 92121 ; 8588052506
• MDR Report Key: 9366397
• MDR Text Key: 168914956
• Report Number: 2027969-2019-00592
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K993317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/22/2019

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 Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/11/2019
• Initial Date FDA Received: 11/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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