MAUDE Adverse Event Report: BECKMAN COULTER ACCESS TOTAL B- HCG; SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN

Model Number ACCESS TOTAL B- HCG

Device Problem High Test Results (2457)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/06/2022

Event Type  Injury  

Manufacturer Narrative

The full patient identifier is (b)(6).The customer did not supply patient demographics such as age, date of birth, weight, ethnicity or race.The access total b-hcg reagent was not returned for evaluation.No hardware errors or issues with other assays were reported in conjunction with this event.No other patient results were called into question.System performance indicators such as system check, calibration and quality control were passing within specifications at the time of the event.In conclusion, the cause of this event cannot be determined with the available information.

Event Description

On (b)(6) 2022 the customer reported erroneous elevated hcg (access total bhcg, 5th is, part number a85264 and lot number 233990) results were generated on the customer's dxi (unicel dxi 600 access immunoassay analyser, part number a30260 and serial number (b)(4)) for one patient.The hcg result of 5 miu/ml was released from the laboratory as a positive result.There was a report of change to patient management in connection with the event.The customer reported the patient had a delay to chemotherapy infusion treatment.The report of 5 miu/ml was questioned by the physician; the laboratory repeat tested the patient sample on their second dxi system (serial number (b)(4)) and obtained a result of 35 miu/ml.The patient was redrawn and the redrawn sample was tested on both of the customer's dxi instruments; results of 1 miu/ml or <1 miu/ml were obtained.No hardware errors or issues with other assays were reported in conjunction with this event.No other patient results were called into question.System performance indicators such as system check, calibration and quality control were passing within specifications at the time of the event.Samples collected were serum samples and lithium heparin samples.No other sample information such as sample volume collected, sample handling and centrifugation time and speed or other sample processing information was provided.

• Brand Name: ACCESS TOTAL B- HCG
• Type of Device: SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN
• Manufacturer (Section D): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• Manufacturer (Section G): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• Manufacturer Contact: angela vettel ; 250 s. kraemer blvd.; brea, CA 92821 ; 7149613625
• MDR Report Key: 15396940
• MDR Text Key: 299670747
• Report Number: 2122870-2022-00046
• Device Sequence Number: 1
• Product Code: DHA
• UDI-Device Identifier: 15099590226213
• UDI-Public: (01)15099590226213(17)230531(11)220531(10)233990
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 09/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: ACCESS TOTAL B- HCG
• Device Catalogue Number: A85264
• Device Lot Number: 233990
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2022
• 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): Other
• Patient Sex: Female