MAUDE Adverse Event Report: BECKMAN COULTER ICON 20 HCG SERUM/URINE TEST; VISUAL, PREGNANCY HCG, PRESCRIPTION USE

Catalog Number 395097A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/22/2016

Event Type  Injury  

Manufacturer Narrative

Manufacturing quality investigated the issue testing retained samples from the lot and customer returned devices using target controls, urine/serum calibrators, and patient sample.Target control and calibrators performed as expected and no false positives were observed.The returned patient sample yielded a positive result on both retains and customer returned devices.The tested lot, 035l11 performed as expected; the sensitivity level of serum sample showed the positive result, all qc negative serum control and clinical negative serum samples showed negative results.When the patient samples were tested with retained lot, the results were positive and the customer's results were verified.When the patient samples mixed with the cocktail of animal iggs were tested, the positive signal was disappeared, suggesting that the samples contained heterophile antibodies.It is concluded that the patient samples contained heterophile antibodies and heterophile antibodies were the cause of false positive results.Since the test employs animal antibodies, human anti-animal antibodies in a sample can interfere the test result.Per icon 20 hch product instructions: the physician should evaluate data obtained with this kit in light of other clinical information.As with any assay employing mouse antibodies, the possibility exists for interference by human anti-mouse antibodies (hama) in the sample.Similarly, specimens from patients who have been routinely exposed to animals or to animal serum products may contain heterophile antibodies which may cause erroneous results.Further testing conducted on the patient's sample by the manufacturer (b)(4) confirmed that the samples contained heterophile antibodies and that the heterophile antibodies were the cause of false positive results.The icon 20 hcg test kit did not malfunction; the issue was related to human anti-mouse antibodies in the patient's specimen.Patient age and weight were not provided by the customer.

Event Description

The customer reported obtaining false positive patient serum test results while using the icon 20 hcg serum/urine test, while quantitative tests and results with patient urine sample showed negative results.The customer then repeated both the urine and serum the following day using fresh samples and the same results were obtained.The patient is not pregnant.Erroneous patient results were reported outside the laboratory.The customer stated that the patient was admitted to the hospital and released the following day; however, it could not be confirmed whether the change to patient treatment was related to the serum test results obtained on the icon 20 hcg test kit.

• Brand Name: ICON 20 HCG SERUM/URINE 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
• Manufacturer Contact: miranda holland ; 11800 sw 147th avenue, 32-s08; miami, FL 33196-2031 ; 3053802031
• MDR Report Key: 5677263
• MDR Text Key: 45858248
• Report Number: 1061932-2016-00467
• Device Sequence Number: 1
• Product Code: JHI
• 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,Followup
• Report Date: 04/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Catalogue Number: 395097A
• Device Lot Number: 035L11
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2015
• 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
• Patient Outcome(s): Hospitalization