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

Model Number	A98143
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Full patient identifier is (b)(6).The customer did not provide patient demographics such as age, date of birth, weight, ethnicity or race.The access accutni+3 reagent was not returned for evaluation.No hardware errors, flags or other assay issues were reported in conjunction with this event.All assay and system verifications met specifications at the time of this event.In conclusion, the cause of this event cannot be determined with the available information.
Event or Problem Description
On (b)(6) 2020 the customer reported that reproducible elevated troponin i (access accutni+3) results had been obtained on the customer's access 2 immunoassay system (part number 81600n and serial number (b)(4)) for one patient.The sample produced a result of 79.30 ng/ml; repeat testing of the same sample produced a result of 77.40 ng/ml.The patient was redrawn and the new sample produced a result of 79.79 ng/ml.The initial results of 79.30 ng/ml and 79.79 ng/ml were released from the laboratory.The customer noted that a troponin test performed at another facility (not provided) on a roche platform (platform details not provided) produced a 'negative' result.The customer did not provide reference ranges.The beckman coulter reference range for the accutni+3 assay is 0.02 (0.01 - 0.05 ng/ml).There was a report of change to patient care or treatment which occurred in connection with this event.The patient was treated for a myocardial infarction.Attempts were made to obtain information regarding specific treatment(s) provided but the customer was unable to provide specific details regarding the treatment(s) provided.System performance indicators such as system check, calibration, precision studies and quality control were performing within specifications at the time of the event.There were no hardware errors, warnings or other flags which occurred at the time of the event.The sample was a mint top becton dickinson (bd) lithium heparin gel separator tube.Sample was noted to be a clean sample.Additional sample handling information such as centrifugation time, speed and temperature or other sample handling information was not provided.

• Brand Name: ACCESS ACCUTNI+3 REAGENT
• Common Device Name: IMMUNOASSAY METHOD, TROPONIN SUBUNIT
• Manufacturer (Section D): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• MDR Report Key: 10212851
• Report Number: 2122870-2020-00055
• Device Sequence Number: 14270659
• Product Code: MMI
• UDI-Device Identifier: 15099590209322
• UDI-Public: (01)15099590209322(17)210131(11)200201(10)921636
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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): 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: A98143
• Device Catalogue Number: A98143
• Device Lot Number: 921636
• Distributor Facility Aware Date: 06/11/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2020
• Initial Report FDA Received Date: 06/30/2020
• 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