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

Model Number	A98143
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/27/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
The full identifier for this event is (b)(6).The access accutni+3 reagent and patient sample were 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.System performance indicators such as system check, calibration and quality control were passing within specifications at the time of the event.The customer verbally confirmed that there is no indication that the accutni+3 result was erroneous.In conclusion, the cause of this event cannot be determined with the available information.
Event or Problem Description
On (b)(6) 2002 beckman coulter was made aware of a patient death potentially associated with the accutni+3 assay (access accutni+3, part number a98143 and lot number 125173) through notification from the fda.One patient sample was tested with the access accutni+3 assay; the sample generated a result which was within the assay's normal reference range.The result was not questioned by physician.Patient sample was not re-tested and no sequential samples from this patient were tested using the access accutni+3 assay following generation of the first accutni+3 result.The patient sample was not tested on any other methodologies and no serial draws were performed by the customer.There was a report of a death.The patient presented with reported chest pain and was treated in the emergency room on (b)(6) 2021, and was subsequently discharged.The patient passed away five days later, not at the hospital.The cause of death is unknown.No hardware errors or issues with other assays were reported in conjunction with this event.No other patient results were called into question.Per the hospital's verbal confirmation, system performance indicators such as system check, calibration and quality control were passing within specifications at the time of the event.Access accutni+3 reagent and calibrator lots met all specifications for release.It was indicated that the patient was under biotin supplementation, it is unknown which dose the patient was receiving.Per the accutni+3 instructions for use, part number b16315 j, the analytical specificity / interferences section, biotin was tested as a potential interfering substance and no interference was observed up to 290 ng/ml.The accutni+3 assay is not intended to be used in isolation; results should be interpreted in conjunction with other diagnostic tests and clinical information.No sample collection or processing information was available.

• Brand Name: ACCUTNI+3 FOR USE ON ACCESS
• 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: 14958054
• Report Number: 2122870-2022-00031
• Device Sequence Number: 5497633
• Product Code: MMI
• UDI-Device Identifier: 15099590209322
• UDI-Public: (01)15099590209322(17)220930(11)210930(10)125173
• 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: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/08/2022

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: 09/30/2022
• Device Model Number: A98143
• Device Catalogue Number: A98143
• Device Lot Number: 125173
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2022
• Initial Report FDA Received Date: 07/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2021
• 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: Death
• Patient Sex: Male