MAUDE Adverse Event Report: PRO ADVANTAGE HCG COMBO CASSETTE (25T); HCG PREGNANCY TEST

Model Number FHC-202

Device Problem False Negative Result (1225)

Patient Problem Pregnancy (3193)

Event Date 02/23/2016

Event Type  Injury  

Manufacturer Narrative

Investigation conclusion: investigation pending.

Event Description

Report received of potential false negative hcg x2 for one patient with proadvantage urine cassette.Patient later confirmed pregnant with repeat urine, serum and ultrasound.(b)(6).No additional patient information provided.

• Brand Name: PRO ADVANTAGE HCG COMBO CASSETTE (25T)
• Type of Device: HCG PREGNANCY TEST
• Manufacturer Contact: ya-ling king ; 9975 summers ridge road; san diego, CA 92121 ; 8588052084
• MDR Report Key: 5644710
• MDR Text Key: 44892917
• Report Number: 2027969-2016-00276
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993065
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FHC-202
• Device Lot Number: HCG5060120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 24 YR