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
On 04jun2020 the customer reported erroneous erratic non-reproducible troponin i (access accutni +3) results were generated on the customer's access 2 immunoassay analyzer (part number 81600n and serial number (b)(4)) over a date range starting on (b)(6) 2020 and ending on (b)(6) 2020.The customer reported that original results were reported out of the laboratory.The customer indicated there was no change to patient treatment or management in conjunction with this event.It is unknown whether the questioned results were erroneously high or low; two written attempts have been made to obtain this information but to date no response has been provided by the customer.Medwatch will address the sample(s) collected on (b)(6) 2020.Medwatch number 2122870-2020-00045 will address the sample(s) collected on (b)(6) 2020.Medwatch number 2122870-2020-00046 will address the sample(s) collected on (b)(6) 2020.Medwatch number 2122870-2020-00047 will address the sample(s) collected on (b)(6) 2020.Medwatch number 2122870-2020-00048 will address the sample(s) collected on (b)(6) 2020.Medwatch number 2122870-2020-00049 will address the sample(s) collected on (b)(6) 2020.Medwatch number 2122870-2020-00050 will address the sample(s) collected on (b)(6) 2020.The customer reported that all 'positive' samples are automatically repeat tested on the access2 immunoassay analyzer.The samples which had results that the customer questioned did not have results which agreed with one another.Customer did not indicate which result were erroneous or if they were erroneously high or low; two written attempts have been made to obtain this information but to date no response has been provided by the customer.Customer supplied data showed that system performance indicators such as system check, calibrations and quality control (qc) were performing within specifications at the time of the event.The customer reported the samples were samples drawn by various laboratory and emergency room (er) personnel in either 12x75 or 13x100 lithium heparin gel tubes.No further sample handling or processing information such as sample handling, centrifugation or storage was provided by the customer.A beckman coulter field service engineer (fse) was dispatched to the customer site.Fse verified system hardware by performing system check, high sensitivity system check and a precision study, all of which returned acceptable results.

• 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: 10181384
• Report Number: 2122870-2020-00044
• Device Sequence Number: 19711395
• 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