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

Model Number ICON 25 HCG,25 TESTS KIT,SERUM/URI

Device Problem Output Problem (3005)

Patient Problem Test Result (2695)

Event Date 09/17/2019

Event Type  malfunction  

Manufacturer Narrative

Retains for icon 25 lot hcg9100038 exp.Jan/31/2021 were pulled for investigation.All serum/urine calibrators, target urine/serum controls were tested on retain devices and customer return customer's devices for this investigation.All results are as expected and no false negatives or positive were observed.The event was escalated to the bec medical director.The medical director requested additional information/clarification related to event.The customer pulled the patient chart and stated, sample collection and hcg test were performed earlier in the day (before noon).There was then an ultrasound performed at 1:00pm the same day, after the serum test was positive.From the patient chart the customer mentioned the patient showed an enlarged fibroid uterus, endometrial cavity of 2-centimeter cyst.The urine specific gravity was not tested.The repeat testing (after two days) was with a beta hcg qualitative testing, not an icon 25 urine/serum test.Sample used for this test was serum.The patient decided to transfer to another provider for a second opinion since an ectopic pregnancy was suspected.Labelling: per ifu pn 43025 ¿ 08109ee.Intended use: the icon®25 hcg test (urine/serum) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hcg) in urine or serum to aid in the early detection of pregnancy.Limitations of the procedure very dilute urine samples, as indicated by a low specific gravity, may not contain representative levels of hcg.If pregnancy is still suspected, a first morning urine sample should be collected 48 hours later and tested.False negative results may occur when the levels of hcg are below the sensitivity level of the test.When pregnancy is still suspected, a first morning urine or serum sample should be collected 48 hours later and tested.Very low levels of hcg (less than 50 miu/ml) are present in urine and serum samples shortly after implantation.However, because a significant number of first trimester pregnancies terminate for natural reasons (5), a test result that is weakly positive should be confirmed by retesting with a first morning urine or serum sample collected 48 hours later.This test reliably detects intact hcg up to 500,000 miu/ml.This test detects intact hcg only.This test does not reliably detect hcg degradation products, including free-beta subunits and beta-core fragment.Therefore, this test may show reduced reactivity in urine after 8 weeks gestation.This test should not be used to monitor trophoblastic disease or post-partum patients.Quantitative assays used to detect hcg may be detecting hcg degradation products, and therefore may disagree with the results of the icon®25 hcg test.A number of conditions other than pregnancy, including trophoblastic disease and certain non-trophoblastic neoplasms including testicular tumors, prostate cancer, breast cancer, and lung cancer, cause elevated levels of hcg (6-7).Therefore, the presence of hcg in urine or serum sample should not be used to diagnose pregnancy unless these conditions have been ruled out.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.Bec internal identifier (b)(4).

Event Description

The customer reported that a urine sample of (b)(6) woman was tested for pregnancy with an icon 25 hcg device, lot number hcg9010038 (exp.Date: jan/31/2021), and the result came as negative.There was no adverse event reported, erroneous result was released to doctor, however no change to patient treatment occurred.The customer stated that the patient had performed 7 over the counter tests in her home and they all resulted in positive results.The clinic tested the patient using urine sample using an icon 25 hcg device and the result generated was negative.The doctor ordered a stat hcg test for confirmation using serum sample.The result came as positive with a hcg level of 554 miu/ml (positive).In addition, an ultrasound was performed the same day.The outcome of the ultrasound was not provided.After two days, the clinic repeated hcg testing using a serum sample again and the concentration of test results was at a higher level, 670 miu/ml.The customer stated that patient is suspected of having an ectopic pregnancy.

• Brand Name: ICON 25HCG URINE/SERUM TEST
• 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; 11800 sw 147th avenue; miami FL 33196 2031
• Manufacturer Contact: laurie o'riordan ; 11800 sw 147th avenue; miami, FL ; 3053802874
• MDR Report Key: 9200180
• MDR Text Key: 207112527
• Report Number: 1061932-2019-01855
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 15099590625917
• UDI-Public: (01)15099590625917(17)200311(11)NO-DATA(10)HCG9010038
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K981512
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/03/2021
• Device Model Number: ICON 25 HCG,25 TESTS KIT,SERUM/URI
• Device Lot Number: HCG9010038
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/18/2019
• Date Manufacturer Received: 09/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 49 YR