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	No Code Available (3191)
Date of Event	07/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Full patient identifier - case-(b)(6).The customer did not provide patient demographics such as age, date of birth, weight, sex, ethnicity or race.The access accutni+3 reagent was not returned for evaluation.No hardware errors or flags were reported in conjunction with this event.It is noted that three (3) days after the event a beckman coulter (bci) field service engineer (fse) was dispatched to the customer's laboratory to perform a preventative maintenance (pm) on the analyzer.It was at this time that the customer reported the non-reproducible result was reported.The fse completed the pm and performed verification testing such as carryover testing, system check, high sensitivity (hs) system check and precision testing.All verification testing passed within published performance specifications.There were no reports of hardware issues by the fse in conjunction with this event.In conclusion, the cause of this event could not be determined with the information supplied.Note: additional access accutni+3 and access bhcg5 patient results were questioned on (b)(6) 2019 along with qc issues.The customer noted that on (b)(6) 2019, when the non-reproducible result was obtained, that the issue seemed to resolve itself after a few hours.Therefore, there were no other assays or patients involved in this event.
Event or Problem Description
The customer contacted beckman coulter (bci) to report obtaining a non-reproducible troponin i (access accutni+3) result for one (1) patient on the laboratory's unicel dxi 600 access immunoassay system serial number (b)(4).The initial result obtained was above the access accutni+3 assay's normal reference range and was reported from the laboratory.Subsequent testing of a second sample from the patient on another analyzer (methodology unknown) produced a significantly lower troponin i result within the assay's normal reference range.There was a change to patient care/management as the patient in question was administered an anticoagulant therapy as a result of the initial, elevated access accutni+3 result.There was no report of death associated with this event.The customer reported that both the access accutni+3 quality control (qc) and the beta-human chorionic gonadotropin (access bhcg5) qc were performing erratically around the timeframe of the reported non-reproducible result.Additionally, two (2) access accutni+3 calibration curves failed in conjunction with this event.A passing access accutni+3 curve was eventually obtained along with a passing access bhcg5 calibration curve.System check was passing within specification at this time.Additional non-reproducible access accutni+3 and access bhcg5 patient results were obtained at the same time as the result in question above.The customer did not supply any sample collection and processing information such as sample type, sample preparation and centrifugation time and speed.There were no reports of issues with sample integrity associated with this event.A bci field service engineer (fse) was dispatched three (3) days later to perform preventative maintenance (pm) on the analyzer.

• 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: 8864327
• Report Number: 2122870-2019-01107
• Device Sequence Number: 13530692
• Product Code: MMI
• UDI-Device Identifier: 15099590209353
• UDI-Public: (01)15099590209353(17)191231(11)181231(10)832157
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K121214
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/06/2019

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: 12/31/2019
• Device Model Number: A98264
• Device Catalogue Number: A98264
• Device Lot Number: 832157
• Distributor Facility Aware Date: 07/15/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2019
• Initial Report FDA Received Date: 08/06/2019
• 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