MAUDE Adverse Event Report: BECKMAN COULTER ACCESS ACCUTNI+3 REAGENT; IMMUNOASAY 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	09/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The full patient identifier is case-(b)(6).The customer did not provide patient demographics such as date of birth, weight, ethnicity or race.: the access accutni +3 reagent was not returned for evaluation.Customer did not note any assay or system issues at the time of the event.Quality control was within range at the time of the event.No hardware errors, flags or other assay issues were reported in conjunction with this event.In conclusion, the cause of this event cannot be determined with the available information.
Event or Problem Description
On 28oct2019, the customer reported that on (b)(6) 2019 an erroneous elevated troponin i (access accutni +3) result was generated for one patient involving the laboratory's access 2 immunoassay system portion of the unicel dxc 600i synchron access clinical system serial number (b)(4).The initial result obtained was 1.03 ng/ml.This sample was repeat tested and a result of 1.12 ng/ml was obtained on (b)(6) 2019.There was a report of change to patient treatment.The customer reported that the patient underwent a treadmill nuclear stress test, ekg and a gated spect scan.The patient was also treated with aspirin and sublingual nitroglycerine.The customer was unable to provide additional details to confirm if these changes to treatment were based solely on the elevated access accutni patient results.The customer is using a reference range of 0.00 - 0.03 ng/ml.The beckman coulter reference range is 0.00 - 0.04 ng/ml.The laboratory noted no issues with quality control.Other system performance indicators such as system checks and calibrations were requested but were not provided for evaluation.The patient's sample was collected in a 13x75 green top becton dickinson (bd) brand tube.Sample was centrifuged at 5000 rpm for 5 minutes and run on the laboratory's access 2 immunoassay system portion of the unicel dxc 600i synchron access clinical system in the primary container.No other sample collection information was provided.

• Brand Name: ACCESS ACCUTNI+3 REAGENT
• Common Device Name: IMMUNOASAY METHOD, TROPONIN SUBUNIT
• Manufacturer (Section D): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• MDR Report Key: 9291201
• Report Number: 2122870-2019-01136
• Device Sequence Number: 2104723
• Product Code: MMI
• UDI-Device Identifier: 15099590209322
• UDI-Public: (01)15099590209322(17)200630(11)190701(10)920946
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): 11/07/2019

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: 06/30/2020
• Device Model Number: A98143
• Device Catalogue Number: A98143
• Device Lot Number: 920946
• Distributor Facility Aware Date: 10/15/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2019
• Initial Report FDA Received Date: 11/07/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 74 YR