Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECKMAN COULTER, INC. ICON 20 HCG PREGNANCY TEST; VISUAL, PREGNANCY HCG, PRESCRIPTION USE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BECKMAN COULTER, INC. ICON 20 HCG PREGNANCY TEST; VISUAL, PREGNANCY HCG, PRESCRIPTION USE Back to Search Results
Model Number 395097
Device Problem False Positive Result (1227)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/15/2022
Event Type  malfunction  
Event Description
High rate of false positive results on beckman coulter icon 20 hcg kits, lot 032h11.False positives have occurred on eight different patients.Dates of occurrence were (b)(6) 2022, (b)(6) 2022, (b)(6) 2022, (b)(6) 2022, (b)(6) 2022, (b)(6) 2022, (b)(6) 2023, and (b)(6) 2023.Results were determined to be false positives based on repeating the urine on another lot of icon 20 hcg kits, running the patients' serum hcg (beckman access 2), and/or ultrasound.Patient ages range from 17 to 45 years.Patients include 7 cis females and 1 transgender male.Approximately 451 tests have been performed on this lot between two locations, (b)(6).Approximate false positive rate is (b)(4).Reference reports: mw5114623, mw5114624, mw5114625, mw5114627, mw5114628, mw5114629, mw5114630.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ICON 20 HCG PREGNANCY TEST
Type of Device
VISUAL, PREGNANCY HCG, PRESCRIPTION USE
Manufacturer (Section D)
BECKMAN COULTER, INC.
brea CA 92821
MDR Report Key16282809
MDR Text Key308726931
Report NumberMW5114626
Device Sequence Number1
Product Code JHJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/31/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/01/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/30/2024
Device Model Number395097
Device Catalogue NumberB3167-50
Device Lot Number032H11
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-