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

Model Number	A98264
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient identifier: the full patient identifier for this event is (b)(6).Age or date of birth, sex, weight, and ethnicity: the customer did not supply patient demographics such as age, date of birth, sex, weight, ethnicity or race.Device evaluated by mfr: the access accutni+3 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.Overall system performance indicators such as system check, calibration and quality control were passing within specifications at the time of the event.On (b)(6) 2021, with guidance from beckman coulter customer technical support, customer performed a 30-replicate precision study; total precision recovery was within assay specifications.In conclusion, the likely cause of this event cannot be determined with the available information.
Event or Problem Description
On (b)(6) 2021, the customer reported obtaining non-reproducible erroneous elevated troponin i (accutni+3 for use on dxi, part number a98264, and lot number 922912) results, generated on the customer's dxi (dxi 600 access immunoassay analyzer, part number a30260 and serial number (b)(4)) for an unknown number of patients.The customer was unable to provide specific dates or sample recovery details for those patient results.There was a report of change to patient treatment or management in association with this event.The customer the patients were held longer in the hospital for monitoring and testing; the customer also reported the patients were admitted to be treated for myocardial infarction (mi).The customer was unable to provide specific details regarding treatment provided to patients.The customer did confirm no death or injury occurred in connection with the event.No hardware errors or issues with other assays were reported in conjunction with this event.Although the customer data included a system check which failed the unwashed portion, repeating the system check with fresh system check solution yielded a passing system check.Overall, system performance indicators such as system check, calibration and quality control results were passing within specifications at the time of the event.Samples were collected in lithium heparin plasma separator tubes, either 13x75 or 13x100 tube size, and centrifuged for 5600 rpm at room temperature.Samples were run in primary tubes.No other sample processing or handling information was provided by the customer.

• Brand Name: ACCESS ACCUTNI+3
• Common Device Name: IMMUNOASSAY METHOD, TROPONIN SUBUNIT
• Manufacturer (Section D): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• MDR Report Key: 12001767
• Report Number: 2122870-2021-00085
• Device Sequence Number: 17041285
• Product Code: MMI
• UDI-Device Identifier: 15099590209353
• UDI-Public: (01)15099590209353(17)220131(11)210131(10)922912(
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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 faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/15/2021

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: 01/31/2022
• Device Model Number: A98264
• Device Catalogue Number: A98264
• Device Lot Number: 922912
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2021
• Initial Report FDA Received Date: 06/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other