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	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The full identifier is case (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.There were no reports of system issues at the time of the event.System performance information such as system check, calibration and quality control (qc) were performing within specifications at the time of the event.No hardware errors or flags were reported in conjunction with the event.A beckman coulter field service engineer (fse) was dispatched to assess system performance but did not identify a hardware, software or system issue that would have contributed to this event.The fse verified the system performance with passing carryover, high sensitivity system check, level sense test, and tnia2 precision studies.Fse also performed two precision studies which passed within 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 non-reproducible elevated troponin i (access accutni +3 assay, part number a98143 and lot number 124535) were generated on the customer's access 2 (access 2 immunoassay analyzer, part number 81600n and serial number (b)(4)) for one patient.The initial elevated troponin i result of 2.43 ng/ml was released from the laboratory.There was a report of change to patient care or management in association with this event.The customer reported the patient was scheduled for a surgical procedure but the surgical procedure was delayed due to the erroneous elevated troponin i result.No additional impact or change to patient treatment was reported in this event.A request for additional information was made regarding the surgical procedure but to date no further information has been received.Subsequent samples were collected from the patient and lower troponin i results were obtained.The initial elevated troponin i result was questioned; the original sample which generated the elevated troponin i result was repeat tested and a lower result (0.00 ng/ml) was obtained.It was noted that the original sample type which generated the erroneous non-reproducible elevated troponin i result was a serum sample and subsequent samples collected were lithium heparin samples.The serum sample was also noted to have been centrifuged for 10 minutes at 3,000 rpm.There were no apparent sample integrity issues noted.No hardware errors or issues with other assays were reported in conjunction with this event.System performance information such as system check, calibration and quality control (qc) were passing within specifications at the time of the event.Sample collection, handling and processing information such as sample volume collected, sample quality, storage temperature and other information was not provided by the customer.A beckman coulter field service engineer (fse) was dispatched to assess system performance.
Event or Problem Description
The customer initially reported surgery was delayed due to the falsely elevated tnia2 result.On (b)(6) 2021, a written attempt was made to obtained additional information regarding the surgery that was delayed.On (b)(6) 2021, the customer further clarified the patient was scheduled for a treadmill stress test, and not a surgery, on (b)(6) 2021 which was canceled due to the elevated tnia2 result of 2.43 ng/ml.The customer did report the patient was taken to the catheter laboratory for an angiogram when the tnia2 result of 2.43 ng/ml was generated; however, the angiogram was canceled when the low troponin result of <0.02 ng/ml was obtained.The customer reported no medication was given to the patient in the catheter laboratory.
Additional Manufacturer Narrative
The customer initially reported surgery was delayed due to the falsely elevated tnia2 result.On (b)(6) 2021, a written attempt was made to obtained additional information regarding the surgery that was delayed.On (b)(6) 2021, the customer further clarified the patient was scheduled for a treadmill stress test, and not a surgery, on (b)(6) 2021 which was canceled due to the elevated tnia2 result of 2.43 ng/ml.The customer did report the patient was taken to the catheter laboratory for an angiogram when the tnia2 result of 2.43 ng/ml was generated; however, the angiogram was canceled when the low troponin result of <0.02 ng/ml was obtained.The customer reported no medication was given to the patient in the catheter laboratory.

• 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: 12583649
• Report Number: 2122870-2021-00160
• Device Sequence Number: 14376241
• Product Code: MMI
• UDI-Device Identifier: 15099590209322
• UDI-Public: (01)15099590209322(17)220630(11)210630(10)124535
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 10/29/2021

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: 06/30/2022
• Device Model Number: A98143
• Device Catalogue Number: A98143
• Device Lot Number: 124535
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/20/2021
• Supplement Date Received by Manufacturer: 10/06/2021
• Initial Report FDA Received Date: 10/06/2021
• Supplement Report FDA Received Date: 10/29/2021
• 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