MAUDE Adverse Event Report: CONSULT DIAGNOSTICS HCG URINE TEST; HCG PREGNANCY TEST

Catalog Number 5001

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 08/14/2019

Event Type  No Answer Provided  

Event Description

Urine pregnancy test was initially negative during 3-5 min read window.Tech returned to the lab and found a faint second line.Was repeated with a serum test (different mfr) and was clearly positive, confirmed with quantitative hcg test showing 5-6 week pregnancy.Mckesson brand, us.Fda safety report id# (b)(4).

• Brand Name: CONSULT DIAGNOSTICS HCG URINE TEST
• Type of Device: HCG PREGNANCY TEST
• MDR Report Key: 8966046
• MDR Text Key: 158638059
• Report Number: MW5089597
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: 5001
• Device Lot Number: HCG8060056
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 31 YR