MAUDE Adverse Event Report: BECKMAN COULTER ICON 25 HCG; VISUAL, PREGNANCY HCG, PRESCRIPTION USE

Catalog Number 43025

Device Problem False Negative Result (1225)

Patient Problems Misdiagnosis (2159); Discomfort (2330); Pregnancy (3193)

Event Date 07/24/2014

Event Type  Injury  

Event Description

The customer reported that on (b)(6) 2014, a patient came in to have iud (intrauterine device) placement.The physician did a urine pregnancy test on icon 25hcg (human chorionic gonadotropin), lot number hcg3100047, and the result was negative.Customer stated that the control line was good and that they waited a full 3 minute-read time, and the customer also had a second person verify the negative result.No icon 25hcg retest or confirmatory hcg serum quantitative test was done at that time.The patient underwent the procedure for iud placement.About 4 weeks later, the patient contacted the customer and complained of discomfort.A quantitative serum test was done and the result came out positive at 163,000 miu/ml hcg, which, according to the customer, is equivalent to about 8 weeks pregnant.No patient sample was saved because their policy is to keep samples for only 48 hours.As a result of the positive hcg serum quantitative test, the patient had the iud removed.Customer reported that there were no known adverse effects to the patient due to the iud placement and removal.

Manufacturer Narrative

Retain and returned test devices of the same lot number were tested with urine and serum negative and positive hcg controls, urine and serum hcg calibrators, and a clinical sample at 139,000 miu/ml hcg.All devices performed as expected and no false negative results were observed.The customer complaint could not be confirmed.All retained and returned devices tested performed as expected.The patient sample was not available from the customer for further analysis.A confirmatory pregnancy test was not performed before the iud placement.Per the instructions for use (ifu) for the icon 25hcg test kit: "this test provides a presumptive diagnosis for pregnancy.A confirmed pregnancy diagnosis should only be made by a physician after all clinical and laboratory findings have been evaluated.".

• Brand Name: ICON 25 HCG
• Type of Device: VISUAL, PREGNANCY HCG, PRESCRIPTION USE
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER; 606 elmwood ave; sharon hill PA 19079 103
• Manufacturer Contact: dung nguyen ; 250 s kraemer blvd; brea, CA 92821 ; 7149614941
• MDR Report Key: 4021683
• MDR Text Key: 4877694
• Report Number: 2518658-2014-00002
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2015
• Device Catalogue Number: 43025
• Device Lot Number: HCG3100047
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention