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

Catalog Number	A85264
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A1: the full patient identifier is (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.The customer tested the same sample after 6 days of storage in a 2-8c refrigerator.Per the bhcg instructions for use (ifu), ¿if the assay will not be completed within 48 hours, or for shipment of samples, freeze at -20c or colder.No other patient results were called into question.The customer was recommended to perform system check and precision run to verify instrument performance.System check passed and the resulting %cv of the precision run was 3.1% which is within the expected variability of the assay per the bhcg ifu.Per the access total bhcg 5th is ifu b29061 p, 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.No further issue was reported by the customer.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) 2025 the customer reported obtaining an erroneous low hcg5 (access total b- hcg, part number a85264, lot number 538701) patient result involving the laboratory's access 2 analyzer serial number (b)(6).The initial result on (b)(6) 2025 was 17.34 miu/ml.When repeated four (4) different times on (b)(6) 2025 the results were 257.88, 261.74, 254.06 and 267.50 (all miu/ml).The customer reported that the patient¿s medication was discontinued due to the initial false low result.No hardware errors or issues with other assays were reported in conjunction with this event.System check was performed on (b)(6) 2025and passed within specifications.Calibration passed on (b)(6) 2025 with reagent lot 538701 and calibrator lot 440507.Overall quality control (qc) material 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: shama agtey ; 1000 lake hazeltine drive; chaska, MN 55318 ; 9524916938
• MDR Report Key: 23551795
• Report Number: 2122870-2025-00110
• Device Sequence Number: 9775326
• Product Code: DHA
• UDI-Device Identifier: 15099590226213
• UDI-Public: (01)15099590226213(17)260731(11)250731(10)538701
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 11/14/2025

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: 07/31/2026
• Device Catalogue Number: A85264
• Device Lot Number: 538701
• 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: 11/05/2025
• Initial Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/31/2025
• 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