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

Model Number	A98143
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Full patient identifier is (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.No hardware errors, flags or other assay issues were reported in conjunction with this event.A beckman coulter laboratory field service engineer (fse) was dispatched to the customer site.Fse reported no hardware interventions performed and no parts replaced.Fse verified the analyzer by obtaining passing system check, high sensitivity system check and precision studies.In conclusion, while the results produced by the access accutni+3 reagent demonstrated precision which was outside of the precision claim contained in the "access accutni+3 instructions for use" precision claim, the root cause of this event cannot be determined with the available information.
Event or Problem Description
Fnc (b)(4).Event occured in (b)(6) on (b)(6) 2020.Description of the incident / incident report: "the medical device fixit was broken during surgery".

• 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: 10181495
• Report Number: 2122870-2020-00049
• Device Sequence Number: 3513951
• Product Code: MMI
• UDI-Device Identifier: 15099590209322
• UDI-Public: (01)15099590209322(17)210131(11)200201(10)921636
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 06/22/2020

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: 01/31/2021
• Device Model Number: A98143
• Device Catalogue Number: A98143
• Device Lot Number: 921636
• Distributor Facility Aware Date: 06/04/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2020
• Initial Report FDA Received Date: 06/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1