MAUDE Adverse Event Report: BECKMAN COULTER ACCESS DIGOXIN REAGENT; ENZYME IMMUNOASSAY, DIGOXIN

Model Number	33710
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer did not provide patient demographics such as age, date of birth, sex, weight, ethnicity, and race.The access digoxin reagent was not returned for evaluation.A beckman coulter field service engineer (fse) was dispatched to the customer's laboratory to evaluate the performance of the instrument.The fse performed preventative maintenance.There was no report of a system performance issue that would have contributed to this event.In conclusion.An assignable cause for this event could not be determined with the information provided.There is no evidence to reasonably suggest a system malfunction; system parameters (system checks, level sense diagnostic testing, qc) met assay and instrument specifications.
Event or Problem Description
The customer reported obtaining non-reproducible digoxin (access digoxin) results on the laboratory's access 2 immunoassay system (serial number (b)(4)) for one patient.The patient's sample was analyzed in triplicate and recovered with imprecise access digoxin results.These results were not released from the laboratory.There was no impact or change to patient care or treatment in association with the non-reproducible access digoxin results.Quality control (qc) was recovering within specifications prior to the event.The customer reported that qc was out of specifications the day following this event.The patient's sample was collected in a plasma separation tube.The customer was not able to provide centrifuge information such as speed, time or temperature.No issues with sample integrity were reported.

• Brand Name: ACCESS DIGOXIN REAGENT
• Common Device Name: ENZYME IMMUNOASSAY, DIGOXIN
• Manufacturer (Section D): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• MDR Report Key: 6908255
• Report Number: 2122870-2017-00050
• Device Sequence Number: 11075407
• Product Code: KXT
• UDI-Device Identifier: 15099590225797
• UDI-Public: (01)15099590225797(17)181031(11)170317(10)633010
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K925802
• 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): 09/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2018
• Device Model Number: 33710
• Device Catalogue Number: 33710
• Device Lot Number: 633010
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/11/2017
• Initial Report FDA Received Date: 10/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1