MAUDE Adverse Event Report: BECKMAN COULTER, INC ACCESS TOTAL SSHCG (5TH IS); SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN

Catalog Number	A85264
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A1: the full patient identifier is case: (b)(4).A2, a3, a4 and a5: the customer did not supply patient demographics such as age, date of birth, sex, weight, ethnicity or race.H3 and h6: the access total b-hcg reagent was not returned for evaluation.No other assay or hardware issue was reported in conjunction with this event.System performance indicators such as system check, calibration and quality control were passing within specifications at the time of the event.No issues with sample integrity were reported by the customer.No other patient results were called into question.Per the access total bhcg 5th is instructions for use (ifu) b29061 l, it states: the access total hcg (5th is) results should be interpreted in light of the total clinical presentation of the patient, including: symptoms, clinical history, data from additional tests, and other appropriate information.If the total hcg result is not consistent with clinical presentation, results should be confirmed by an alternate hcg method or a urine-based assay.In conclusion, a cause for this event could not be determined with the information provided.There is no evidence to reasonably suggest that a malfunction occurred in conjunction with this event.
Event or Problem Description
On (b)(6) 2024, the customer reported obtaining erroneously elevated hcg5 results for one patient (access total b- hcg) involving the laboratory's unicel dxi 600 access immunoassay analyser (serial number sn: (b)(6).The initial result received for the sample was 55.0 miu/ml on (b)(6) 2024.When the same sample was repeated on the same instrument two days later the result was 1.2 miu/ml.The sample was also repeated on an alternate dxi analyzer, sn: (b)(6), and the result was 1.1 miu/ml.The customer noted that patient treatment changed due to the false high result.The patient¿s medication dosage was adjusted to lower due to the false high result (medication unknown).The customer reported that the patient was not harmed by any of the changes.No further information was provided.No hardware errors or issues with other assays were reported in conjunction with this event.Calibration passed on (b)(6) 2024 with reagent lot: 439671 and calibrator lot: 439577.Quality control (qc) has been passing within the laboratory¿s established ranges.No issues with samples integrity were reported by the customer.No further information was provided.

• Brand Name: ACCESS TOTAL SSHCG (5TH IS)
• Common Device Name: SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN
• Manufacturer (Section D): BECKMAN COULTER, INC; 1000 lake hazeltine drive; chaska MN 55318
• Manufacturer (Section G): BECKMAN COULTER, INC; 1000 lake hazeltine drive; chaska MN 55318
• Manufacturer Contact: angela vettel ; 250 s. kraemer blvd.; brea, CA 92821 ; 7149613625
• MDR Report Key: 20693006
• Report Number: 2122870-2024-00043
• Device Sequence Number: 18318028
• Product Code: DHA
• UDI-Device Identifier: 15099590226213
• UDI-Public: (01)15099590226213(17)250630(11)240630(10)439671
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K221990
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/15/2024

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: 06/30/2025
• Device Catalogue Number: A85264
• Device Lot Number: 439671
• 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: 11/13/2024
• Initial Report FDA Received Date: 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/30/2024
• 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: Unknown