Elecsys Digoxin 07027214190Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04015630940400), received between Jan 20, 2023 and Jan 20, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “High Test Results” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 20, 2023High Test Results; High Test Results

  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).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16213761 ↗