Syva® Emit® Lidocaine Assay 10445369Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00842768001390), received between Jan 7, 2020 and Jan 7, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Low 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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 7, 2020Low Test Results; Low Test Results

  IT WAS REPORTED THAT A DISCORDANT DEPRESSED LIDOCAINE RESULT WAS OBTAINED ON A PATIENT SAMPLE PROCESSED (B)(6) 2019 ON A NON-SIEMENS INSTRUMENT USING THE SIEMENS SYVA EMIT LIDOCAINE REAGENT. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN. THE ORIGINAL SERUM SAMPLE WAS RE-PROCESSED ON THE SAME SYSTEM AND A NEGATIVE RESULT WAS OBTAINED. THE CUSTOMER STATED THAT THE DISCORDANT INITIAL LIDOCAINE RESULT WAS REPORTED TO THE PHYSICIAN. THE CUSTOMER INFORMED SIEMENS THAT ON A LATER DATE (AND SUBSEQUENT TO THE DEATH OF THE PATIENT) A PHARMACIST QUESTIONED THE DEPRESSED LIDOCAINE RESULT AND THE SAME PATIENT SAMPLE WAS REPROCESSED AT THAT TIME USING THE SAME SIEMENS SYVA EMIT LIDOCAINE REAGENT ON THE SAME NON-SIEMENS SYSTEM. A HIGHER RESULT WAS OBTAINED AND A CORRECTED REPORT WAS ISSUED. THE CUSTOMER STATED THAT THE PATIENT EXPIRED ON (B)(6) 2019. THE EXACT TIME OF THE PATIENT EXPIRATION HAS NOT BEEN PROVIDED. THE CUSTOMER INFORMED SIEMENS THAT THE LABORATORY PATHOLOGIST STATED THAT THE PATHOLOGIST REPORT AT THE HOSPITAL WHERE THE PATIENT EXPIRED INDICATED THAT "THE DEATH WAS CARDIAC ARREST MOST LIKELY DUE TO LIDOCAINE TOXICITY." THE CUSTOMER STATED THAT LIDOCAINE QUALITY CONTROL RESULTS

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 9557731 ↗
• MalfunctionJan 7, 2020Low Test Results; Low Test Results

  IT WAS REPORTED THAT A DISCORDANT DEPRESSED LIDOCAINE RESULT WAS OBTAINED ON A PATIENT SAMPLE PROCESSED (B)(6) 2019 ON A NON-SIEMENS INSTRUMENT USING THE SIEMENS SYVA EMIT LIDOCAINE REAGENT. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN. THE CUSTOMER STATED THAT THE DISCORDANT INITIAL LIDOCAINE RESULT WAS REPORTED TO THE PHYSICIAN. THE CUSTOMER INFORMED SIEMENS THAT ON A LATER DATE (AND SUBSEQUENT TO THE DEATH OF THE PATIENT) A PHARMACIST QUESTIONED THE DEPRESSED LIDOCAINE RESULT AND THE SAME PATIENT SAMPLE WAS REPROCESSED AT THAT TIME USING THE SAME SIEMENS SYVA EMIT LIDOCAINE REAGENT ON THE SAME NON-SIEMENS SYSTEM. A HIGHER RESULT WAS OBTAINED AND A CORRECTED REPORT WAS ISSUED. THE CUSTOMER STATED THAT THE PATIENT EXPIRED ON (B)(6) 2019. THE EXACT TIME OF THE PATIENT EXPIRATION HAS NOT BEEN PROVIDED. THE CUSTOMER INFORMED SIEMENS THAT THE LABORATORY PATHOLOGIST STATED THAT THE PATHOLOGIST REPORT AT THE HOSPITAL WHERE THE PATIENT EXPIRED INDICATED THAT "THE DEATH WAS CARDIAC ARREST MOST LIKELY DUE TO LIDOCAINE TOXICITY." THE CUSTOMER STATED THAT LIDOCAINE QUALITY CONTROL RESULTS WERE WITHIN LABORATORY REFERENCE RANGES ON THE DATE OF TESTING. STATEMENTS AND ACTIONS ATTRIBUTED

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 9557725 ↗