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	04/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The full patient identifier for this event is case-(b)(6).The customer did not supply patient demographics such as age, date of birth, sex, weight, ethnicity or race.The access accutni+3 was not returned for evaluation.A beckman coulter laboratory support specialist (lss) was dispatched to the customer site.While onsite, the lss performed interference testing using heterophile blockers (hbr-1, mouse igg, goat igg and bovine igg) and alkaline phosphatase blocker pool (scav-alp + ap mutein) on the sample collected on (b)(6) 2020.Testing results demonstrated patient-sourced interferents of heterophiles and alkaline phosphatase were present in the patient sample.In conclusion, the cause of this event is the presence of known patient-sourced interferents in the patient's samples.
Event or Problem Description
On (b)(6) 2020, the customer reported obtaining multiple reproducible elevated troponin i (access accutni+3) results for one patient involving the laboratory's unicel dxi 800 immunoassay system (part number 973100 and serial number (sn) (b)(4).Samples were collected and tested on the customer's unicel dxi 800 sn (b)(4) over several days: (b)(6) 2020 (troponin i result of 0.01 ng/ml); (b)(6) 2020 (troponin i result of 0.12 ng/ml); (b)(6) 2020 (0.11 ng/ml); and (b)(6) 2020 (0.12 ng/ml).The customer did not provide a reference range; the beckman coulter accutni+3 reference range is 0.00 - 0.04 ng/ml.There was a report of change to patient treatment or management which occurred in connection with this event.The patient underwent an angiogram (date not provided) due to the elevated troponin i results.Results of angiogram testing were normal.No further information was provided regarding change to or impact to patient care was reported in connection with this event.System performance indicators such as system check and calibration were passing within specifications at the time of the event.Quality control testing results were not provided for review.No issues with sample collection were reported by the customer.No information regarding sample collection tubes, centrifugation, storage or other information was provided.

• 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: 9987872
• Report Number: 2122870-2020-00026
• Device Sequence Number: 2092725
• Product Code: MMI
• UDI-Device Identifier: 15099590209353
• UDI-Public: (01)15099590209353(17)200531(11)190601(10)920945
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K172787
• 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): 04/22/2020

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: 05/31/2020
• Device Model Number: A98264
• Device Catalogue Number: A98264
• Device Lot Number: 920945
• Distributor Facility Aware Date: 04/09/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2020
• Initial Report FDA Received Date: 04/22/2020
• 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