MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS DIGOXIN; ENZYME IMMUNOASSAY, DIGOXIN

Catalog Number	07027214190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product labeling states: "digoxin-like immunoreactive substances (dlis) have been identified in blood from patients with renal failure, liver failure, and pregnant women in their third trimester.Studies have shown that the presence of dlis in a sample can result in a false elevation of digoxin when assayed by commercially available immunoassays." the sample was requested for investigation.
Event or Problem Description
The initial reporter questioned a high result for 1 patient tested for elecsys digoxin (digoxin) on a cobas e 801 analytical unit.On (b)(6) 2022 the result from the abbott method was 1.87 ug/l.On (b)(6) 2022 the result from the e801 module was 3.22 ug/l.This result did not correspond to the patient¿s clinical condition.The result from the e801 module was reported outside of the laboratory.The customer suspects an interference affecting the roche result as the patient has renal failure; this is mentioned in the product labeling for the assay.The e801 module serial number was (b)(4).
Additional Manufacturer Narrative
Section d4, lot number expiration date was updated.Calibration was last performed on (b)(6) 2022 with acceptable results.Qc was acceptable.Between (b)(6) 2022 and (b)(6) 2023, 169 sample-related alarms were observed.Product labeling states: "digoxin-like immunoreactive substances (dlis) have been identified in blood from patients with renal failure, liver failure, and pregnant women in their third trimester.Studies have shown that the presence of dlis in a sample can result in a false elevation of digoxin when assayed by commercially available immunoassays." since the patient suffers from renal failure, digoxin-like immunoreactive substances (dlis) could have contributed to the high result.As the sample was not received for investigation the cause of the event could not be determined.The investigation did not identify a product problem.

• Brand Name: ELECSYS DIGOXIN
• Common Device Name: ENZYME IMMUNOASSAY, DIGOXIN
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16213761
• Report Number: 1823260-2023-00189
• Device Sequence Number: 17235787
• Product Code: KXT
• UDI-Device Identifier: 04015630940400
• UDI-Public: 04015630940400
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K961824
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2023

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: 10/31/2023
• Device Catalogue Number: 07027214190
• Device Lot Number: 62634101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2023
• Supplement Date Received by Manufacturer: 01/30/2023
• Initial Report FDA Received Date: 01/20/2023
• Supplement Report FDA Received Date: 02/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 88 YR
• Patient Sex: Male