Digoxin 20737836322Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04015630915682), received between Feb 4, 2022 and Jun 25, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (2 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2024Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE DIG DIGOXIN RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS 6000 C 501 (UL) V. THE INITIAL RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. CALIBRATION AND QC ISSUES PROMPTED THE RERUN OF THE PATIENT SAMPLE. THE INITIAL RESULT WAS 1.04 NG/ML. THE FIRST REPEAT RESULT WAS 0.55 NG/ML. THE SECOND REPEAT RESULT WAS 0.92 OR 0.94 NG/ML. THE THIRD REPEAT RESULT WAS 0.62 NG/ML. NO RESULT WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19605379 ↗
• MalfunctionJun 25, 2024Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE DIG DIGOXIN RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS 8000 COBAS C 502 MODULE. THE INITIAL RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE REPORTER STATED THAT FOUND A CLOT IN THE PATIENT SAMPLE UPON RECHECK BUT THEY DID NOT RECEIVE ANY CLOT ERROR ALARMS, PROMPTING THE RERUN OF THE PATIENT SAMPLE. THE INITIAL RESULT WAS 0 BUT WAS CONVERTED AND AUTO-VERIFIED TO <0.6 NG/ML WITH A DATA FLAG. THE REPEAT RESULT WAS 1.59 NG/ML. THIS RESULT WAS REPORTED AS 1.6 NG/ML. THE REPEAT RESULT WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19604748 ↗
• MalfunctionJan 5, 2024High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE DIGOXIN RESULT FROM THE COBAS 8000 COBAS C 502 MODULE. THE CUSTOMER ALLEGED AN INTERFERENCE. THE RESULT FOR THE FIRST SAMPLE WAS 0.66 NG/ML. THE PHYSICIAN QUESTIONED THE RESULT AS THE PATIENT WAS NOT GIVEN DIGOXIN AS PART OF THE MEDICAL TREATMENT. THE SAMPLE WAS REPEATED ON A COBAS E8010 ANALYZER AND THE RESULT WAS <0.2 NG/ML WITH A DATA FLAG. A NEW SAMPLE WAS COLLECTED FROM THE PATIENT AND HAD THE SAME RESULTS. NO SPECIFIC DATA WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18456179 ↗
• MalfunctionNov 10, 2023Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE DIG DIGOXIN RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS 6000 C501 MODULE. THE INITIAL RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE INITIAL RESULT FROM THE MODULE WITH THE PATIENT SAMPLE IN A TUBE WAS 0.30 NG/ML WITH A DATA FLAG. THE FIRST REPEAT RESULT FROM THE MODULE WITH THE PATIENT SAMPLE IN A TUBE WAS 0.40 NG/ML. THE SECOND REPEAT RESULT FROM THE MODULE WITH THE PATIENT SAMPLE IN A CUP WAS 0.35 NG/ML. THE THIRD REPEAT RESULT FROM THE MODULE WITH THE PATIENT SAMPLE IN A CUP WAS 0.59 NG/ML. THE FOURTH REPEAT RESULT FROM ANOTHER C 501 WITH THE PATIENT SAMPLE IN A CUP WAS 0.50 NG/ML. THE FIFTH REPEAT RESULT FROM ANOTHER C 501 WITH THE PATIENT SAMPLE IN A CUP WAS 0.51 NG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18111345 ↗
• MalfunctionFeb 4, 2022Incorrect Measurement; Incorrect Measurement

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR THREE SAMPLES COLLECTED FROM THE SAME PATIENT AND TESTED WITH DIG DIGOXIN ON A COBAS 6000 C (501) MODULE. THE SAMPLE RESULTS DID NOT AGREE WITH THE CLINICAL PICTURE OF THE PATIENT. THE RESULTS FROM THE FIRST TWO SAMPLES WERE REPORTED OUTSIDE OF THE LABORATORY. THE RESULT FROM THE THIRD SAMPLE WAS NOT REPORTED OUTSIDE OF THE LABORATORY. PRIOR TO THE COMPLAINED SAMPLES, A SAMPLE FROM THE PATIENT RESULTED IN A DIGOXIN VALUE OF 0.83 NMOL/L ON (B)(6) 2022. ON OR AFTER (B)(6) 2021, THE PATIENT STARTED TAKING UREA MEDICATION. THE DIGOXIN LEVELS OF THE PATIENT ROSE AFTER THE INTRODUCTION OF THIS MEDICATION. THE FIRST COMPLAINED SAMPLE RESULTED IN A DIGOXIN VALUE OF 1.62 NMOL/L ON (B)(6) 2022. THE SECOND COMPLAINED SAMPLE RESULTED IN A DIGOXIN VALUE OF 1.89 NMOL/L ON (B)(6) 2022. THIS MEASUREMENT WAS PERFORMED ONE DAY AFTER DIGOXIN MEDICATION WAS DISCONTINUED. THE THIRD COMPLAINED SAMPLE RESULTED IN A DIGOXIN VALUE OF 1.52 NMOL/L ON (B)(6) 2022. THE SERIAL NUMBER OF THE C 501 ANALYZER IS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13453478 ↗