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

Model Number	A98264
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/25/2021
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, sex, 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.System performance indicators such as system check, calibration and quality control were passing within specifications at the time of the event.Additionally, a precision run performed on (b)(6) 2021 met assay precision specifications.In conclusion, the cause of this event cannot be determined with the available information.
Event or Problem Description
On (b)(6) 2021 the customer reported erroneous non-reproducible elevated troponin i (access accutni+3 for use on dxi, part number a98264 and lot number 922912) were generated on the customer's dxi 800 (dxi 800 access immunoassay w/dual gantry, part number a71457 and serial number (b)(4)) for one (1) patient.The initial result was 4.51 ng/ml (00:13); the sample was repeat tested and a result of 0.00 ng/ml (07:36) was obtained.The customer did not provide a reference range; the beckman coulter reference range for troponin i is <0.04 ng/ml.There was a report of change to patient treatment or management in connection with this event.The patient was admitted to the hospital and administered lovenox (dosage not provided).The patient was discharged the same day after the result of 0.00 ng/ml was obtained at 07:36.System performance indicators such as system check, calibration and quality control were performing 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.A precision run performed by the customer on (b)(6) 2021 passed within assay specifications.The customer noted the sample was slightly hemolyzed.Sample handling information such as sample type, centrifugation time, speed and temperature and aliquotting information was not provided by the customer.

• 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: 12150394
• Report Number: 2122870-2021-00101
• Device Sequence Number: 3768481
• 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: WI
• 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): 07/12/2021

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: 06/25/2021
• Initial Report FDA Received Date: 07/12/2021
• 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