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

Model Number	A98143
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The full patient identifier is case (b)(4).The customer did not supply patient demographics such as age, date of birth, sex, weight, ethnicity or race.There is sufficient evidence to suggest an imprecision malfunction occurred as 3 or more replicates of the same sample on the same device recovered outside the expected assay precision.A beckman coulter field service engineer (fse) was dispatched to assess the instrument's performance.There was no report of hardware parts replaced in connection with this event.The fse verified the transducer temperature.The fse reported slight adjustments were made to the reagent and sample carousel, and proactively adjusted the ultrasonic voltages and the mixer motor speed.The fse inspected the fluidic block and verified no bubbles were visible.After performing adjustments and visually inspecting the instrument, the fse verified the system performance with system check, tnia2 precision studies and quality control.Although the fse serviced the instrument, a definitive cause of the imprecision malfunction cannot be determined with the available information.The root cause of this event cannot be determined with the available information.
Event or Problem Description
On (b)(6) 2020 the customer reported obtaining erratic troponin i (access accutni+3) results for one patient involving the laboratory's access 2 immunoassay analyzer (serial number (b)(4)).The following results (b)(6) were questioned due to the erratic nature of the results.The expected or correct results were not specified in this event.A second sample was tested with similar results at (b)(6).The customer reference range is 0.00 - 0.02 ng/ml.No affect to patients or end-users has been reported in connection with this event.The customer reported the patient was sent to the hospital for further evaluation due to the repeatable high results and not due to the erroneously low result that was still considered positive.Any treatment given based on the erroneous result generated would have been similar.Any additional impact or change to patient treatment has not been specified in this event.The customer has not provided further information on any change or impact to patient treatment.A beckman coulter field service engineer (fse) was dispatched to the customer site on 23jan2020.Available system performance indicators of system check, calibration and quality control did not demonstrate an issue with the system.The fse proactively adjusted the pipettor alignments, ultrasonic voltages and mixer speed.There was no report of hardware parts replaced in connection with the event and no report of issues with other assays.Sample tube collection type was a bd lihep tube 13x75 mint top.The customer reported that the sample was centrifuged for 15 minutes at 3500 rpm.There was no report of sample integrity issues, the sample was clean.No further sample information was 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: 9699017
• Report Number: 2122870-2020-00017
• Device Sequence Number: 1742072
• Product Code: MMI
• UDI-Device Identifier: 15099590209322
• UDI-Public: (01)15099590209322(17)200831(11)190901(10)921220
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 02/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: A98143
• Device Catalogue Number: A98143
• Device Lot Number: 921220
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/23/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2020
• Initial Report FDA Received Date: 02/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1