MAUDE Adverse Event Report: HENRY SCHEIN HCG URINE CASSETTE 25T; HCG PREGNANCY TEST

Model Number FHC-102-KHS25

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/17/2015

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 urine cutoff control all results were positive at 3 min read time and met qc specification.Manufacturing batch record review did not uncover any abnormalities.Per package insert, "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

Email received from distributor alleging customer received fn hcg.Patient had positive home pregnancy tests.Exact time unknown.Customer observed negative urine test results at the clinic at 3 minute read time - but customer said she saw a faint test line appear at 6 minutes.Quant was 49 miu/ml.Patient's last menstrual period unknown.It was reported patient had taken a shot of lupron for endometriosis.Patient had an ultrasound on (b)(6) 2015.Patient confirmed to be six weeks pregnant.Estimated delivery date (b)(6) 2016.No adverse patient sequela reported.No additional details reported.

• Brand Name: HENRY SCHEIN HCG URINE 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: 5311492
• MDR Text Key: 33902897
• Report Number: 2027969-2015-01018
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/30/2015

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-KHS25
• Device Lot Number: HCG5020025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/30/2015
• Initial Date FDA Received: 12/18/2015
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 31 YR