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	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The full identifier is case(b)(4).The customer did not provide patient demographics such as age, date of birth, sex, weight, ethnicity or race.The access accutni+3 reagent was not returned for evaluation.There were no reports of system issues at the time of the event.System performance information such as system check, calibration and quality control (qc) were performing within specifications at the time of the event.No hardware errors or flags were reported in conjunction with the event.The customer noted the laboratory has observed problems with samples containing fibrin.The likely cause of this event is use error.The customer was testing samples which contain fibrin.Per access accutni+3 instructions for use, b16316 h ¿remove any residual fibrin or cellular matter.Failure to do so can contribute to falsely elevated results.¿ there is no evidence to reasonably suggest an instrument malfunction.
Event or Problem Description
On 08apr2021 the customer reported a non-reproducible elevated troponin i result (access accutni +3 assay, part number a98264 and lot number 922912) were generated on the customer's dxi 600 (dxi 600 access immunoassay analyzer, part number a71460 and serial number (b)(4)) on 06apr2021.The customer did not provide specific result obtained but stated the result, above customer upper reference limit (url) of <0.04 ng/ml, was reported outside of the laboratory.The customer reported a change to patient care or treatment in connection with this event.The customer reported one patient was admitted and received a chest ct scan with dye, x-rays and an ekg.The patient was released after corrected troponin i results were obtained.Specific details regarding troponin i, ct, x-ray and ekg results were not provided.No hardware errors or issues with other assays were reported in conjunction with this event.System performance indicators such as system check, calibration and quality control (qc) were passing within specifications at the time of the event.Sample was a lithium heparin plasma sample and processed using customer's automation line.Centrifugation conditions were not provided by the customer.The customer noted the laboratory has observed problems with samples containing fibrin.No other sample collection or processing 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: 11681384
• Report Number: 2122870-2021-00047
• Device Sequence Number: 3473995
• Product Code: MMI
• UDI-Device Identifier: 15099590209353
• UDI-Public: (01)15099590209353(17)220131(11)210131(10)922912
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 04/16/2021

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: 01/31/2022
• Device Model Number: A98264
• Device Catalogue Number: A98264
• Device Lot Number: 922912
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2021
• Initial Report FDA Received Date: 04/16/2021
• 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