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

Model Number	A98264
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).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.No hardware errors or other assay issues were reported in conjunction with this event.A beckman coulter field service engineer (fse) was dispatched to assess the instrument's performance on (b)(6) 2021 and adjusted ultrasonics.He ran 100 repetitions of troponin using wash buffer as sample and did not obtain any flyer.Another fse went to the customer site on (b)(6) 2021 to observe pre-analytical specimen handling.He indicated that no pre-analytical issue was seen with no fibrin or cellular debris within samples.The customer is running all accutni+3 patient samples in duplicate and is investigating any discrepancies.In conclusion, although the fse serviced the instrument, the root cause of this event cannot be determined with the available information.
Event or Problem Description
On (b)(6) 2021 the customer reported obtaining false non-reproducible troponin i (access accutni+3) result for one patient involving the laboratory's dxi 800 access immunoassay w/spot b analyzer (serial number (b)(4)).Despite multiple attempt have been made to get additional information on patient results, no additional information was provided.One patient was sent to the catheterization laboratory but, despite multiple attempt, it is unknown if the patient has been catheterized or not.No hardware errors or other assay issues were reported in conjunction with this event.Calibration passed on (b)(6) 2021 with reagent lot 922912 and calibrator lot 922646.Quality control (qc) was passing within the laboratorys established ranges.A beckman coulter field service engineer (fse) was dispatched to the customer on (b)(6) 2021 and adjusted ultrasonics.He ran 100 repetitions of troponin using wash buffer as sample and did not obtain any flyer.Another fse went to the customer site on (b)(6) 2021 to observe pre-analytical specimen handling.He indicated that no pre-analytical issue was seen with no fibrin or cellular debris within samples.The customer is running all accutni+3 patient samples in duplicate and is investigating any discrepancies.Sample information such as sample collection tube used, centrifugation time and speed, storage or handling was not provided by the customer.There was no report of sample integrity issues.No further sample information was provided.
Additional Manufacturer Narrative
Per the internal tnidx nrfp investigation, the precipitant found in the conjugate well of the accutni+3 dxi reagent lot 922911/922912 correlates with the non-reproducible fliers observed at some customer sites.This issue was not consistently reproducible on dxi instruments evaluated during this investigation.Over 20 dxi instruments were screened using a standard protocol and only 1 instrument was found to reproduce the issue.Additionally, the amount of precipitant in the conjugate well varied among reagent packs lot 922911/922912.Although precipitant was identified in the conjugate wells of alternate lots of accutni+3 dxi, there were no noted increase in flier rates.In conclusion, the cause of this event could not be determined with the available information.There is no evidence to suggest that a malfunction occurred in conjunction with this event.Although hardware intervention was performed and precipitant may have contributed to this issue, there is not enough information to determine the cause of this event.

• 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: 11759910
• Report Number: 2122870-2021-00059
• Device Sequence Number: 14187879
• 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: IL
• 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): 07/23/2021

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?: Yes
• Distributor Facility Aware Date: 04/08/2021
• Initial Date Received by Manufacturer: 04/08/2021
• Supplement Date Received by Manufacturer: 07/21/2021
• Initial Report FDA Received Date: 05/03/2021
• Supplement Report FDA Received Date: 07/23/2021
• 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