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	Insufficient Information (4580)
Date of Event	10/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The full patient identifier is (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 issues with other assays were reported in conjunction with this event.System performance indicators of passing system checks, quality control recovery, and precision study did not demonstrate an issue with the system.No other patient results were called into question.The customer reported the lithium heparin tube was incompletely filled.Short draw samples are known to affect immunoassays by modifying blood to additive ratio.The access accutni+3 for use on the access 2 reagent ifu (document (b)(4), available on the beckman coulter website) specimen section states, ¿the role of pre-analytical factors in laboratory testing has been described in a variety of published literature.¿ following blood collection tube manufacturers¿ specimen collection and handling recommendations are essential to reduce pre-analytical errors.Additionally, as per clsi guideline-gp44-a4: procedures for the handling and processing of blood specimens for common laboratory tests 4th edition, ¿if less blood than required is drawn, the excess amount of additive has the potential to adversely affect the accuracy of test results¿.In conclusion, use error is the cause of this event.The customer did not follow the ifu (instructions for use) and the clsi (clinical and laboratory standards institute) guidelines for preanalytical sample handling.There is no evidence to suggest a reagent or hardware malfunction was the cause of the event.
Event or Problem Description
On (b)(6) 2021 the customer reported obtaining one non-reproducible false high troponin i (access accutni+3) result involving the laboratory's access 2 section, dxc 600i packaged analyzer (serial number (b)(4)).On (b)(6) 2021, a falsely elevated tnia2 result of 1.64 ng/ml was generated for one patient sample.The elevated tnia2 result was questioned as a subsequent sample draw recovered at 0.01 ng/ml and 0.01 ng/ml.The sample that produced the 1.64 ng/ml result was repeated and results of 0.01 ng/ml and 0.01 ng/ml were also obtained.The patient was admitted based on the falsely elevated tnia2 result and treatment was started.Patient treatment provided was not specified in this event.No further information has been provided.Calibration passed on (b)(6) 2021 using reagent lot 124772 and calibrator lot 922645.Quality control was within acceptable range.Passing system checks were obtained on (b)(6) 2021 and (b)(6) 2021.No hardware errors or issues with other assays were reported in conjunction with this event.No other patient results were called into question.On (b)(6) 2021, the customer ran a 15 replicate tnia2 precision study which recovered at 2.75 ng/ml mean, 0.05 sd (standard deviation), and 1.99 %cv (percent coefficient of variation).The customer reported the lithium heparin tube was incompletely filled.The customer stated that the tube was about half full.

• 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: 12688761
• Report Number: 2122870-2021-00170
• Device Sequence Number: 17389918
• Product Code: MMI
• UDI-Device Identifier: 15099590209322
• UDI-Public: (01)15099590209322(17)220731(11)210731(10)124772
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 10/25/2021

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: 07/31/2022
• Device Model Number: A98143
• Device Catalogue Number: A98143
• Device Lot Number: 124772
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/12/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2021
• Initial Report FDA Received Date: 10/25/2021
• 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