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	01/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The full patient identifier is (b)(6).The customer did not supply patient demographics such as age, date of birth, weight, ethnicity or race.Available system performance indicators of calibration and quality control did not demonstrate an issue with the system.The customer sent patient samples to beckman coulter for interference testing.Interference testing by the complaint handling unit identified presence of patient-source heterophile and alkaline phosphatase-associated interferents in the patient sample.In conclusion, the cause of the reproducible elevated access accutni +3 results is a patient source interferent.
Event or Problem Description
On 15jan2020, the customer reported that on (b)(6) 2020 at 23:58, a reproducible elevated troponin i (access accutni +3) result of 0.128 ng/ml was generated on the laboratory's dxi 600 immunoassay analyzer (part number a71460 and serial number (b)(4)) for one patient.The initial elevated result was reported out of the laboratory.The customer's troponin i (access accutni +3) reference range is <0.03 ng/ml.The sample was also tested for troponin using an i-stat device; a result 0.00 ng/ml was obtained.The customer's i-stat troponin reference range is 0.00 - 0.08 ng/ml.There was a report of change to patient care or treatment which occurred in connection with this event.The customer reported the patient was admitted to the hospital due to the elevated troponin results and uncontrolled blood pressure.The patient was treated medically for these symptoms in the emergency room and admitted for cardiac evaluation and possible stress test.Cardiology consult completed (b)(6) 2020 for nonstemi (non-st segment elevated myocardial infarction) and hypertensive emergency.Ekg (electrocardiogram) and echocardiogram were completed and patient had lexiscan stress test performed (b)(6) 2020.The stress test was negative and the patient was discharged later the same day.Medications administered to the patient while in the emergence room included: zofran 4mg iv (intravenously), morphine 2 mg iv, nitroglycerine 2% 1gm acw (anterior chest wall) , aspirin 325 mg, lovenox 100 mg subq (subcutaneously), cozaar 50 mg po (by mouth), omnipaque iv contrast for a ct (computerized tomography) scan, normal saline iv fluids.Calibration and quality control were performing within specifications at the time of the event.No issues with sample integrity were reported by the customer.

• 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: 9646866
• Report Number: 2122870-2020-00008
• Device Sequence Number: 19528965
• Product Code: MMI
• UDI-Device Identifier: 15099590209353
• UDI-Public: (01)15099590209353(17)200930(11)191001(10)921254
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 01/30/2020

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 Model Number: A98264
• Device Catalogue Number: A98264
• Device Lot Number: 921254
• Distributor Facility Aware Date: 01/15/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2020
• Initial Report FDA Received Date: 01/30/2020
• 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