MAUDE Adverse Event Report: BECKMAN COULTER ACCESS ACCUTNI+3 REAGENT; IMMUNOASSAY METHOD, TROPONIN SUBUNIT

Model Number	A98143
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	Misdiagnosis (2159)
Date of Event	08/14/2020
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 date of birth, weight, ethnicity or race.The access troponin i reagent was not returned for evaluation.No hardware errors, flags or other assay issues were reported in conjunction with this event.No other patient results were called into question.No issues with sample integrity were reported by the customer.Although interference is suspected, an interference testing have not been performed due to insufficient volume of sample.The cause of this event cannot be determined with the available information.
Event or Problem Description
On (b)(6) 2020, the customer reported obtaining reproducible false elevated troponin i (access accutni+3) results for one patient involving the laboratory's access 2 immunoassay analyzer (serial number (b)(4)).One patient went to hospital for chest pain on (b)(6) 2020, the accutni+3 result was high at 5.57 ng/ml.The electrocardiogram ecg showed sinus bradycardia, incomplete right bundle branch to block pattern and early repolarization changes.On (b)(6) 2020, the accutni+3 result was similar high at 5.36 ng/ml.Five other access accutni+3 retests (three on the same instrument, two on a dxi analyzer) have been performed during the hospitalization and all were elevated above the reference range of 0.04 ng/ml and discordant with the patient clinical file.The access accutni+3 results were also discordant with the point-of-care testing (poct) (no further information provided) performed on (b)(6) 2020, (<0.02 ng/ml) and with the abbott ctni result performed on (b)(6) 2020, (0.001 ng/ml).The results of other myocardial enzymes (including myoglobin, ck-mb, ck, bnp and ldh) were all negative (data not provided) and discordant with the access accutni+3 results.The customer reported that a cardiac color ultrasound was performed, and no abnormality was observed in the cardiac structure, and blood flow.Then a coronary angiography under local anesthesia was performed, and did not show obvious vascular stenosis.There is malfunction as results obtained from at least one different device, and the patient¿s clinical presentation are categorically different from results obtained from a beckman coulter device.No interference testing could have been performed due to insufficient volume of sample.Sample tube collection type was not provided.Sample processing information such as centrifugation time, speed and temperature were not provided.There was no report of sample integrity issues.No further sample 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: 10521320
• Report Number: 2122870-2020-00075
• Device Sequence Number: 14346425
• Product Code: MMI
• UDI-Device Identifier: 15099590209322
• UDI-Public: (01)15099590209322(17)210331(11)200331(10)921806
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 09/11/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: A98143
• Device Catalogue Number: A98143
• Device Lot Number: 921806
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/02/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2020
• Initial Report FDA Received Date: 09/11/2020
• 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
• Patient Age: 22 YR