MAUDE Adverse Event Report: CONSULT HCG URINE CASSETTE 5001- 25T; HCG PREGNANCY TEST

Model Number FHC-A102-OBC554

Device Problem False Negative Result (1225)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 09/06/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: customer's observation was not replicated in-house with retention devices.Retention devices were tested with 20 miu/ml hcg urine cutoff control and 3 high level of hcg urine controls.All results were positive at 3 min read time and met qc specification.Manufacturing batch record review did not uncover any abnormalities.Per pi, "false negative results may occur when the levels of hcg are below the sensitivity level of the test.When pregnancy is still suspected, a first morning urine specimen should be collected 48 hours later and tested." root cause could not be determined 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 false negative urine hcg on consult hcg urine cassette 5001- 25t.Customer stated line appeared after designated read time, leading customer to order a beta quant which yielded 83 miu/ml.Customer said they might have performed a procedure on a patient such as an endometrial biopsy, but this was not planned for this particular patient.Patient came to women's health association due to late menses.Date of event/testing: (b)(6) 2016.Patient's lmp: (b)(6) 2016.No injury or invasive procedures were performed based on the false negative result.No treatment withheld based on the false negative result.No reported adverse patient sequela.

• Brand Name: CONSULT HCG URINE CASSETTE 5001- 25T
• Type of Device: HCG PREGNANCY TEST
• Manufacturer Contact: ya-ling king ; 9975 summers ridge road; san diego, CA 92121 ; 8588052084
• MDR Report Key: 6000843
• MDR Text Key: 56554968
• Report Number: 2027969-2016-00639
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062361
• 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: 09/08/2016

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-A102-OBC554
• Device Lot Number: HCG6030192
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/08/2016
• Initial Date FDA Received: 10/05/2016
• 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: 39 YR