MAUDE Adverse Event Report: BECKMAN COULTER 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	05/02/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The full patient identifier is (b)(4).The customer did not supply patient demographics such as age, date of birth, sex, weight, ethnicity or race.The access accutni+3 reagent was not returned for evaluation.A beckman coulter field service engineer (fse) was dispatched to assess system performance.Fse performed precision study, system check, high sensitivity system check and carryover test, all of which returned acceptable results indicating the system is performing within specifications.Fse noted the customer was using non-gel lithium heparin tubes.Fse noted centrifuge was functioning properly but there was a buffer of lightly mixed cells between plasma and red blood cell (rbc) layer.Customer stated that occasionally the centrifuge would leave rbc trails along the side of the tube during processing.Fse advised customer to make aliquots, and check sample integrity, prior to testing.In conclusion, although sample handling may have contributed to the event, the cause of the event cannot be determined with the available information.
Event or Problem Description
On 04may2022 the customer reported that on (b)(6) 2022, an erroneous non-reproducible elevated troponin i (access accutni+3, part number a98264 and lot number 125664) was generated for one patient on the customer's dxi (dxi 600 access immunoassay analyzer w/spot b, part number a71460 and serial number (sn) (b)(4).The result of 0.07 ng/ml was reported out of the laboratory.There was a report of change to patient treatment or management in connection with the event.The customer reported that the patient was sent for an angiogram.No further information regarding patient treatment or outcome was provided.Patient was redrawn and sample was run on customer's other dxi (dxi 600 access immunoassay analyzer w/spot b, part number a71460 and sn (b)(4) and result of 0.00 ng/ml was obtained.The original sample was then retested on dxi sn (b)(4) and a result of 0.01 ng/ml was obtained.The original sample was then tested on dxi sn (b)(4) and a result of 0.03 ng/ml was obtained.The second sample was also tested in duplicate on dxi sn (b)(4) and results of 0.01 ng/ml and 0.00 g/ml were obtained.System performance indicators such as calibration and quality control (qc) were passing within specifications at the time of the event.No hardware errors or other assay issues were reported in conjunction with the event.No other patient sample results were questioned.Samples were collected in non-gel lithium heparin tubes and centrifuged at 3600rpms for 10 minutes.Samples were noted to be clear.Samples were tested from original sample tubes and not recentrifuged prior to retesting.No other sample handling information was provided.A beckman coulter field service engineer (fse) was dispatched to assess system performance.

• Brand Name: 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: 14402629
• Report Number: 2122870-2022-00023
• Device Sequence Number: 17505804
• Product Code: MMI
• UDI-Device Identifier: 15099590209353
• UDI-Public: (01)15099590209353(17)221231(11)211231(10)125664
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K121790
• 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): 05/13/2022

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: 12/31/2022
• Device Model Number: A98264
• Device Catalogue Number: A98264
• Device Lot Number: 125664
• 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: 05/04/2022
• Initial Report FDA Received Date: 05/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2021
• 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