ONLINE TDM Digoxin 08057613190Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613336121214), received between Dec 2, 2022 and Oct 4, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “High Test Results” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 4, 2024Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE DIGOXIN RESULTS FROM THE COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 0.00 NG/ML WITH A DATA FLAG. THE SAMPLE WAS REPEATED 10 TIMES AND THE RESULT WAS ALWAYS 0.00 NG/ML WITH A DATA FLAG. THE SAMPLE WAS REPEATED ON A UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM (BECKMAN) INSTRUMENT AND THE RESULT WAS 0.33 NG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20369679 ↗
• MalfunctionMar 15, 2024High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE DIGOXIN (DIG) RESULTS FROM THE COBAS C 503 ANALYTICAL UNIT THAT SIS NOT MATCH THE CLINICAL PICTURE FOR THE PATIENTS. THE CUSTOMER ALLEGED MANY PATIENT SAMPLES HAD RESULTS AROUND 0.4 AND 0.6 WITHOUT ANY DIGOXIN TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18914795 ↗
• MalfunctionMar 7, 2024High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE DIGOXIN RESULT FROM THE COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 0.45 G/L FOR A SAMPLE THAT WAS EXPECTED TO HAVE A NEGATIVE RESULT. AS THE RESULTS DID NOT AGREE WITH THE PATIENT'S CLINICAL PICTURE, THE SAMPLE WAS SENT TO ANOTHER LABORATORY WHERE IT WAS TESTED WITH ABBOTT METHODOLOGY AND WITH MASS SPECTROMETRY. NO SPECIFIC DATA WAS PROVIDED, BUT THE RESULTS WERE CONSIDERED TO BE NEGATIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18857499 ↗
• MalfunctionDec 2, 2022Low Test Results; Low Test Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED FOR DIGOXIN (DIG) ON A COBAS PRO C 503 ANALYTICAL UNIT. THE INITIAL RESULT OF THE FIRST SAMPLE TESTED ON THE C503 MODULE WAS < 0.3¿G/L. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY WHERE IT WAS QUESTIONED BY THE DOCTOR AS IT WAS NOT PLAUSIBLE. THE SAMPLE WAS REPEATED ON A COBAS C6000 SYSTEM WITH A RESULT OF < 0.3¿G/L. THE INITIAL RESULT FOR THE SECOND SAMPLE (NEW BLOOD DRAWN ON 28-OCT-2022) TESTED ON THE C503 MODULE WAS < 0.3¿G/L. THE SAMPLE WAS REPEATED ON A COBAS C6000 SYSTEM WITH A RESULT OF < 0.3¿G/L. THE PATIENT WAS SENT TO ANOTHER LABORATORY WHERE A NEW SAMPLE WAS OBTAINED AND THE RESULT FROM A COBAS 8000 SYSTEM WAS 0.76 UG/L. A THIRD SAMPLE WAS OBTAINED ON 03-NOV-2022. A SERUM SAMPLE AND A LITHIUM HEPARIN SAMPLE WERE OBTAINED AT THE SAME TIME. THE SERUM SAMPLE WAS TESTED ON THE C503 MODULE WITH A RESULT OF 0.3 UG/L. THE LITHIUM HEPARIN SAMPLE WAS SENT TO THE OTHER LABORATORY AND THE RESULT FROM A COBAS 8000 SYSTEM WAS 1.0 UG/L. THE HIGH RESULTS FROM THE OTHER LABORATORY (1.0 G/L AND 0.76 G/L) WERE CONSIDERED TO BE CORRECT. THE C503 MODULE SERIAL NUMBER WAS (B)(4). THE SERIAL NUMBERS FOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15910805 ↗