MAUDE Adverse Event Report: BECKMAN COULTER, INC. ICON 25HCG URINE/SERUM TEST; VISUAL, PREGNANCY HCG, PRESCRIPTION USE

Model Number	ICON 20 HCG BOX OF 25 TESTS
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The failure mode could not be determined conclusively with the information provided.There is no evidence of a systemic issue.A complaint search was performed from (b)(6)2023 through current day (b)(6)2024 and there were no other false negative results reported for lot number 034c11.A nonconformance search was performed for pn 395097a lot 034c11, within timeframe of (b)(6)2023 through current day (b)(6)2024 and no similar nonconformance was found for this issue indicating no manufacturing non-conformance occurred and product met all release specifications.The product ifu pn 395127 for icon 20 hcg serum/urine test states the following: · specimen collection and preparation: o for optimal early detection of pregnancy, a first morning urine specimen is preferred since it generally contains the highest concentration of hcg.However, randomly collected urine specimens may be used.· limitations: o an extremely low concentration of hcg during the early stage of pregnancy can give a negative result.In this case, testing of another specimen obtained at least 48 hours later is recommended.O urine samples collected after consumption of a large amount of fluids may contain a lower hcg concentration.If such a sample is negative, a first morning specimen should be obtained and retested.O the physician should evaluate data obtained with this kit in light of other clinical information.Section a2, a4, and a5: information not provided by customer.The beckman coulter internal identifier is (b)(4).
Event or Problem Description
The customer reported that the icon 20 hcg tests for lot 034c11 generated false negative results for two patients.The customer stated they followed the testing procedure when a false negative result was obtained for two patients.One patient confirmed the pregnancy by using an alternate method the next day with no delay or impact to treatment.The second patient reported having right lower quadrant pain for some time and suspected a pregnancy.On (b)(6)2024, the icon 20 hcg test was performed and yielded a false negative for the presence of hcg, the action plan for treatment shifted focus from pregnancy to abdominal pain.On (b)(6)2024, the patient returned presenting the same ongoing symptoms, blood was drawn and the blood test confirmed the presence of beta-hcg and the patient's pregnancy.There was no report of medical intervention required as results of the change in patient treatment and no impact to the pregnancy.
Event or Problem Description
The customer reported that the icon 20 hcg tests for lot 034c11 generated false negative results for two patients.The customer stated they followed the testing procedure when a false negative result was obtained for two patients.One patient confirmed the pregnancy by using an alternate method the next day with no delay or impact to treatment.The second patient reported having right lower quadrant pain for some time and suspected a pregnancy.On (b)(6) 2024, the icon 20 hcg test was performed and yielded a false negative for the presence of hcg, the action plan for treatment shifted focus from pregnancy to abdominal pain.On (b)(6) 2024, the patient returned presenting the same ongoing symptoms, blood was drawn and the blood test confirmed the presence of beta-hcg and the patient's pregnancy.There was no report of medical intervention required as results of the change in patient treatment and no impact to the pregnancy.
Additional Manufacturer Narrative
The failure mode could not be determined conclusively with the information provided.There is no evidence of a systemic issue.A complaint search was performed from 02-dec-2023 through current day 30-dec-2024 and there were no other false negative results reported for lot number 034c11.A nonconformance search was performed for pn 395097a lot 034c11, within timeframe of 02-dec-2023 through current day 30-dec-2024 and no similar nonconformance was found for this issue indicating no manufacturing non-conformance occurred and product met all release specifications.The product ifu pn 395127 for icon 20 hcg serum/urine test states the following: specimen collection and preparation: for optimal early detection of pregnancy, a first morning urine specimen is preferred since it generally contains the highest concentration of hcg.However, randomly collected urine specimens may be used.Limitations: an extremely low concentration of hcg during the early stage of pregnancy can give a negative result.In this case, testing of another specimen obtained at least 48 hours later is recommended.Urine samples collected after consumption of a large amount of fluids may contain a lower hcg concentration.If such a sample is negative, a first morning specimen should be obtained and retested.The physician should evaluate data obtained with this kit in light of other clinical information.Section a2, a4, and a5: information not provided by customer.Follow up 1: section h4 manufacturing date has been documented.The beckman coulter internal identifier is (b)(4).

• Brand Name: ICON 25HCG URINE/SERUM TEST
• Common Device Name: VISUAL, PREGNANCY HCG, PRESCRIPTION USE
• Manufacturer (Section D): BECKMAN COULTER, INC.; 250 s. kraemer blvd; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER, INC.; 11800 sw 147th avenue; miami FL 33196 2031
• Manufacturer Contact: angela vettel ; 250 s. kraemer blvd; brea, CA 92821 ; 7149613625
• MDR Report Key: 21050440
• Report Number: 1061932-2024-00017
• Device Sequence Number: 21147836
• Product Code: JHI
• UDI-Device Identifier: 15099590625948
• UDI-Public: (01)15099590625948(17)251130(11)240403(10)034C11
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K020439
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2025
• Device Model Number: ICON 20 HCG BOX OF 25 TESTS
• Device Catalogue Number: 95097
• Device Lot Number: 034C11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2024
• Supplement Date Received by Manufacturer: 12/05/2024
• Initial Report FDA Received Date: 12/31/2024
• Supplement Report FDA Received Date: 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female