MAUDE Adverse Event Report: BECKMAN COULTER ACCESS HIGH SENSITIVITY TROPONIN I REAGENT; IMMUNOASSAY METHOD, TROPONIN SUBUNIT

Model Number	A98143
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).The access accutni+3 reagent was not returned for evaluation.All assay and system verifications met specifications at the time of this event.No hardware errors, flags or other assay issues were reported in conjunction with this event.A passing precision run was performed on 17apr2020.In addition, the customer stated that a small clot was observed in the sample floating on top of the serum.Clot was removed prior to retesting.Preanalytical sample handling was the likely cause of the erroneous access accutni+3 result obtained.In conclusion, use error, due to improper sample handling, is the cause of this event.
Event or Problem Description
On (b)(6) 2020 the customer reported that a non-reproducible elevated troponin i (access accutni+3) result had been generated on the customer's access 2 section, dxc 600i packaged (serial number (b)(4)) for one patient sample.The initial elevated access accutni+3 result of 6.12 ng/ml was released from the laboratory.The result was questioned by nurse or physician.The day after, the customer reported retesting twice the sample on the same anayzer; both repeated results were 0.00 ng/ml.The customer normal reference range is < 0.04 ng/ml.There was a report of change to patient care or treatment which occurred in connection with this event.The patient was administered heparin.No report of additional changes to patient management was reported.Calibration and quality control were performing within specifications at the time of the event.System checks were performed on 03apr2020, 10apr2020 and 17apr2020 and passed within specifications.The sample was a serum sample, collected and tested in a serum separator tube with gel and centrifuged for 10 minutes at 3750 rpm (1960 g) at room temperature.A small clot was observed floating on top of the serum and removed before the sample was retested.

• Brand Name: ACCESS HIGH SENSITIVITY TROPONIN I REAGENT
• Common Device Name: IMMUNOASSAY METHOD, TROPONIN SUBUNIT
• Manufacturer (Section D): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• MDR Report Key: 10020179
• Report Number: 2122870-2020-00036
• Device Sequence Number: 3052993
• Product Code: MMI
• UDI-Device Identifier: 15099590209322
• UDI-Public: (01)15099590209322(17)201031(11)191101(10)921317
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/04/2020

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: 10/31/2020
• Device Model Number: A98143
• Device Catalogue Number: A98143
• Device Lot Number: 921317
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/17/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2020
• Initial Report FDA Received Date: 05/04/2020
• 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