MAUDE Adverse Event Report: BECKMAN COULTER ACCESS ACCUTNI+3; IMMUNOASSAY METHOD, TROPONIN SUBUNIT

Model Number	A98143
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022 the customer reported obtaining non-reproducible troponin i (access accutni+3, part number a98143 and lot number 124772) results on the customer's access 2 (access 2 immunoassay analyzer, part number a25640 and serial number (b)(4)) for one patient sample.The initial result of 0.55 ng/ml was released from the laboratory.Retesting of the patient sample generated a troponin i result of 0.02 ng/ml; a corrected report was issued.The customer reported a change to patient treatment which occurred in connection with this event.Details of the change to patient treatment were requested by beckman coulter but were not provided.System performance indicators such as system check, calibration and quality control were passing within specifications at the time of the event.No hardware errors or issues with other assays were reported in conjunction with this event.No other patient results were called into question.Sample type, collection, processing and handling information was not provided by the customer.
Additional Manufacturer Narrative
The full patient identifier is (b)(4).The customer did not provide patient demographics such as age, date of birth, sex, weight, ethnicity or race.The access accutni+3 reagent was not returned for evaluation.System performance indicators were passing within specifications.Customer-performed precision study using cardiac controls level 1 and 2 and obtained acceptable results.In conclusion, the cause of this event cannot be determined with the available information.

• Brand Name: ACCESS ACCUTNI+3
• Common Device Name: IMMUNOASSAY METHOD, TROPONIN SUBUNIT
• 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: 13535615
• Report Number: 2122870-2022-00008
• Device Sequence Number: 4063901
• Product Code: MMI
• UDI-Device Identifier: 15099590209322
• UDI-Public: (01)15099590209322(17)220731(11)210731(10)124772
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K121214
• 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): 02/15/2022

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: 07/31/2022
• Device Model Number: A98143
• Device Catalogue Number: A98143
• Device Lot Number: 124772
• 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: 01/28/2022
• Initial Report FDA Received Date: 02/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2021
• 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