MAUDE Adverse Event Report: CONSULT HCG DIPSTICK TEST 5000 25T; HCG PREGNANCY TEST

Model Number FHC-101-OBC517

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: the customer's observation was not replicated in-house with retention products.Retention products were tested with 25 miu/ml and 100 miu/ml hcg urine controls.Retention products showed hcg positive results at read time for both the controls and met qc specifications.No false negative results were obtained.Manufacturing batch record review did not uncover any abnormalities.Based on the information available, there is no indication of a product deficiency and no corrective action is required.

Event Description

The customer reported a false negative hcg result for a patient using a consult hcg dipstick test 5000 25t as compared to a positive quantitative hcg result of 451 miu/ml.The urine sample collected for the consult hcg dipstick test was not a first morning urine sample.The false negative hcg result occurred approximately two weeks prior to the date of this report.No additional information is available per the customer.The timing between the two tests is unavailable.

• Brand Name: CONSULT HCG DIPSTICK TEST 5000 25T
• Type of Device: HCG PREGNANCY TEST
• Manufacturer Contact: ya-ling king ; 9975 summers ridge road; san diego, CA 92121 ; 8588052084
• MDR Report Key: 6110109
• MDR Text Key: 60293315
• Report Number: 2027969-2016-00683
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993203
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FHC-101-OBC517
• Device Lot Number: HCG6040183
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2016
• Initial Date FDA Received: 11/17/2016
• 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