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	No Code Available (3191)
Date of Event	03/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).A beckman coulter field service engineer (fse) was dispatched to assess the instrument's performance.The fse performed hardware checks and replaced the peri-pump tubing.The fse performed pipettor tip alignments and adjustments, and performed mixer speed adjustment.The fse primed the system to check for air and leaks.After repair, the fse performed system check and a ten point precision for low and high quality control with acceptable results.The likely cause of this event is a defective peri-pump tubing to the aspirate probe.
Event or Problem Description
On (b)(6) 2020 the customer reported obtaining one non reproducible false elevated troponin i (access accutni+3) result for one patient involving the laboratory's access 2 immunoassay analyzer (serial number (b)(4)).The initial result 0.728 ng/ml was questioned due to the erratic nature of the result and was repeated on the same analyzer with a discordant result (0.010 ng/ml).A second sample was tested with similar low results at 0.014 ng/ml and 0.010 ng/ml.The customer reported the patient was given heparin as treatment.The customer stated there was no death or injury to patient due to associated results.Any additional impact or change to patient treatment has not been specified in this event.The customer stated no instrument errors posted prior to patient run and qc was passing prior to patient run.A beckman coulter field service engineer (fse) was dispatched to the customer site on 04mar2020.The fse performed hardware checks and replaced the peri-pump tubing.The fse performed pipettor tip alignments and adjustments, and performed mixer speed adjustment.The fse primed the system to check for air and leaks.After repair, the fse performed system check and a ten point precision for low and high quality control with acceptable results.There were no reports of other issues with this assay.There were no reports of issues with other assays.There were no reports of other instrument issues.Sample tube collection type was bd's lithium heparin green top tubes.The customer stated the samples were full draws and samples were not hemolyzed, lipemic and no clots observed.The customer reported samples were centrifuged at 3600 rpm for 6 minutes.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: 9849266
• Report Number: 2122870-2020-00022
• Device Sequence Number: 16328836
• Product Code: MMI
• UDI-Device Identifier: 15099590209322
• UDI-Public: (01)15099590209322(17)201231(11)200101(10)921442
• 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): 03/18/2020

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: 12/31/2020
• Device Model Number: A98143
• Device Catalogue Number: A98143
• Device Lot Number: 921442
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 03/04/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2020
• Initial Report FDA Received Date: 03/18/2020
• 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