MAUDE Adverse Event Report: CONSULT HCG URIN/SRM COMBO 5002-25T; HCG PREGNANCY TEST

Model Number FHC-A202-OBC554

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/19/2015

Event Type  malfunction  

Manufacturer Narrative

Customer's observation was not replicated in-house with retention devices.Retention devices were tested with 20 miu/ml hcg urine control and 3 high level of hcg urine controls (201.8 iu/ml, 203.4 iu/ml and 205.2 iu/ml); all results were hcg positive at read time.No false negatives were obtained.Manufacturing batch record review did not uncover any abnormalities.Root cause could not be determined without patient specimen in-house analysis and insufficient information provided.Based on the information available, there is no indication of a product deficiency.No corrective action is required at this time.This issue will be subject to tracking and trending.

Event Description

Caller reported a potential false negative urine hcg result with consult hcg urine/serum combo test.The patient was in the physician's office to confirm the positive results she observed with two urine tests performed at home.The patient's last menstrual period is unknown and no further patient details were provided.The first test performed in the physician's office gave a clearly negative result at 3 minutes.After the patient questioned the result, two more tests were performed with the same sample and both gave positive results.Physician diagnosis was "pregnant," did not request blood confirmation or any other supporting test.Patient did not receive any unnecessary procedure/treatment or treatment withheld based on the first urine test.Patient went home with routine pregnancy care.

• Brand Name: CONSULT HCG URIN/SRM COMBO 5002-25T
• Type of Device: HCG PREGNANCY TEST
• Manufacturer Contact: ya-ling king ; 9975 summers ridge rd.; san diego, CA 92121 ; 8588052084
• MDR Report Key: 5291958
• MDR Text Key: 33347482
• Report Number: 2027969-2015-01006
• 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: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/19/2015

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 Expiration Date: 09/30/2016
• Device Model Number: FHC-A202-OBC554
• Device Lot Number: HCG4110217
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/19/2015
• Initial Date FDA Received: 12/12/2015
• 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