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 No Consequences Or Impact To Patient (2199)

Event Date 04/11/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: customer's observation was not replicated in-house with retention devices.Retention devices were tested with 25 miu/ml hcg cutoff urine control hcg urine control; all results were hcg positive at read time and met qc specification.No false negatives were obtained.Manufacturing batch record review did not uncover any abnormalities.The root cause could not be determined based on the information provided by the customer and without patient specimen in-house analysis.Based on the information available, there is no indication of a product deficiency.No corrective action is required at this time.

Event Description

Report received of potential false negative hcg for one patient with proadvantage urine cassette.Patient's lmp (b)(6) 2016.On (b)(6) 2016 proadvantage negative, alere cassette positive, sample collected 11:51 am.On (b)(6) 2016 proadvantage positive, collected at 8:07 am.No serum drawn.No reported adverse patient sequela.

• 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: 5645438
• MDR Text Key: 44894259
• Report Number: 2027969-2016-00308
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FHC-202
• Device Lot Number: HCG5050147
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/13/2016
• Was Device Evaluated by Manufacturer?: No
• 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 Age: 28 YR