ADVIA® 2120i Hematology System 10285573Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00630414560045), received between Aug 14, 2017 and Aug 18, 2024 — classified as 28 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (4 reports).

1 FDA recall record name this device's identifier, 1 still open.

20 other recalls cover devices cleared under the same FDA submission (K102644); they may or may not involve this specific model.

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.

Recalls naming this device

1. Mar 5, 2021Class IIOpen, Classified

   Potential Sample Identification (SID) Mismatch with14-Character Barcodes

   Z-1391-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED AN ERRONEOUSLY FALSELY ELEVATED PLATELET RESULT WAS OBTAINED ON AN ADVIA® 2120I HEMATOLOGY SYSTEM, SERIAL NUMBER: (B)(6). THE FALSELY ELEVATED PATIENT RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAMPLE WAS REPROCESSED ON THE SAME SYSTEM AND RECOVERED SIMILAR TO THE INITIAL RESULT. THE SAMPLE WAS REPROCESSED A SECOND TIME ON AN ALTERNATE ADVIA® 2120I HEMATOLOGY SYSTEM AND RECOVERED LOWER. THE SAMPLE WAS PROCESSED A THIRD TIME ON A NON-SIEMENS INSTRUMENT AND RECOVERED LOWER. THE LOWER RESULT FROM THE ALTERNATE ADVIA® 2120I HEMATOLOGY SYSTEM WAS CORRECT, REPORTED, AND WAS SIMILAR TO A HISTORICAL RESULT. THERE IS NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19999315 ↗
• MalfunctionMar 31, 2023Mechanical Problem; Mechanical Problem

  DUE TO A MISALIGNMENT OF THE BARCODE READER ON AN ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER, INCORRECT SAMPLE IDENTIFIERS WERE ASSIGNED TO PATIENT SAMPLES ACROSS TWO DAYS (B)(6) 2023. AS A RESULT, 580 SAMPLES WERE REPEATED ON ALTERNATE ADVIA 2120/2120I HEMATOLOGY SYSTEMS, AND 280 REPEAT RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIANS. SEVEN PATIENTS WERE REDRAWN TO OBTAIN CORRECT RESULTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16657904 ↗
• MalfunctionMar 31, 2023Mechanical Problem; Mechanical Problem

  DUE TO A MISALIGNMENT OF THE BARCODE READER ON AN ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER, INCORRECT SAMPLE IDENTIFIERS WERE ASSIGNED TO PATIENT SAMPLES ACROSS TWO DAYS (B)(6) 2023. AS A RESULT, 580 SAMPLES WERE REPEATED ON ALTERNATE ADVIA 2120/2120I HEMATOLOGY SYSTEMS, AND 280 REPEAT RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). SEVEN PATIENTS WERE REDRAWN TO OBTAIN CORRECT RESULTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16657605 ↗
• MalfunctionNov 10, 2022Use of Device Problem; Use of Device Problem

  AS THE CUSTOMER WAS CLEANING THE CENTERING COLLAR ON THE LABORATORY'S ADVIA 2120I HEMATOLOGY SYSTEM, HER HAND SLIPPED AND HER FINGER WAS POKED BY THE AUTOSAMPLER NEEDLE. THE CUSTOMER WAS WEARING GLOVES AT THE TIME OF THE EVENT. THE CUSTOMER WASHED THE CUT WITH SOAP AND WATER AND THEN WENT TO THE EMERGENCY ROOM. THE CUSTOMER WAS GIVEN POST EXPOSURE PROPHYLAXIS (PEP) MEDICATION. THE CUSTOMER WAS ALSO GIVEN AN INJECTION WITH A HIGH PLASMA CONCENTRATION TO BOOST HER IMMUNITY. THE CUSTOMER WILL HAVE TO HAVE FOLLOW-UP TESTING AT 1, 3 AND 6 MONTHS. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15776005 ↗
• MalfunctionApr 18, 2022Leak/Splash; Leak/Splash

  WHILE INSPECTING A LEAK ON THE LABORATORY'S ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER, THE CUSTOMER WAS SPLASHED ON THE FACE WITH A MIXTURE OF BLOOD AND RINSE SOLUTION. THE CUSTOMER WAS NOT WEARING SAFETY GOGGLES NOR A FACE SHIELD, AND SHE DID NOT KNOW IF THE SPLATTER HIT HER EYES. THE CUSTOMER SUBSEQUENTLY HAD HER BLOOD TESTED AFTER THE EVENT. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14137828 ↗
• MalfunctionNov 13, 2020Low Test Results; Low Test Results

  A DISCORDANT, FALSELY LOW PLATELET RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S) AND WAS QUESTIONED. THE SAMPLE WAS REPEATED FOR PLATELET ON AN ALTERNATE ADVIA 2120I HEMATOLOGY SYSTEM, RESULTING HIGHER. THE HIGHER RESULT WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW PLATELET RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10838428 ↗
• MalfunctionSep 18, 2020Failure to Read Input Signal; Failure to Read Input Signal

  THE CUSTOMER REPORTED THAT AN EXTRA CHARACTER IS OCCASIONALLY ADDED TO THE END OF THE PATIENT SAMPLE IDS WHEN THE SAMPLE BARCODE IS READ BY THE AUTOSAMPLER BARCODE READER ON THE CUSTOMER'S ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER. THE EXTRA CHARACTER ADDED IS RANDOM AND CAN CHANGE FOR THE SAME SAMPLE ID ACROSS MULTIPLE ASPIRATIONS. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10557073 ↗
• MalfunctionJul 16, 2020High Test Results; High Test Results

  A DISCORDANT, FALSELY ELEVATED PLATELET RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER. THE SAMPLE WAS REPEATED ON THE SAME SYSTEM FOR PLATELET, AND RECOVERED HIGHER THAN THE INITIAL DISCORDANT RESULT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. THE PLATELET COUNT WAS THEN ASSESSED MANUALLY, RESULTING LOWER. THIS REPEAT RESULT WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED PLATELETS RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10286895 ↗
• MalfunctionApr 23, 2020High Test Results; High Test Results

  DISCORDANT, FALSELY ELEVATED HEMOGLOBIN (HGB), HEMATOCRIT (HCT), AND RED BLOOD CELL (RBC) RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON AN ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER (SERIAL NUMBER: (B)(4)). THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND WERE QUESTIONED. THE SAME SAMPLE WAS RERUN FOR HGB, HCT, AND RBC ON THE CUSTOMER'S ALTERNATE ADVIA 2120I HEMATOLOGY SYSTEM, RESULTING LOWER. THE REPEAT RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). DISCORDANT, FALSELY ELEVATED HGB AND HCT RESULTS WERE ALSO OBTAINED ON A SECOND PATIENT SAMPLE USING THE ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER (SERIAL NUMBER: (B)(4)). THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND WERE QUESTIONED. THE SAME SAMPLE WAS REPEATED FOR HGB AND HCT ON THE SAME SYSTEM, RESULTING LOWER. THE SAME SAMPLE WAS THEN RERUN FOR HGB AND HCT ON THE CUSTOMER'S ALTERNATE ADVIA 2120I HEMATOLOGY SYSTEM, ALSO RESULTING LOWER AND CONFIRMING THE REPEAT RESULTS. THE REPEAT RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALS

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9990459 ↗
• MalfunctionDec 20, 2019Low Test Results; Low Test Results

  DISCORDANT, FALSELY LOW COMPLETE BLOOD COUNT (CBC) PARAMETERS WERE OBTAINED ON TWO PATIENT SAMPLES ON AN ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER. THE DISCORDANT PARAMETERS INCLUDE WHITE BLOOD CELLS (WBC), RED BLOOD CELLS (RBC), HEMOGLOBIN (HGB), HEMATOCRIT (HCT), AND PLATELETS (PLT). THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE TWO PATIENT SAMPLES WERE REPEATED FOR WBC, RBC, HGB, HCT, AND PLT ON AN ALTERNATE ADVIA 2120I HEMATOLOGY SYSTEM, RESULTING HIGHER. THESE RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW WHITE BLOOD CELLS (WBC), RED BLOOD CELLS (RBC), HEMOGLOBIN (HGB), HEMATOCRIT (HCT), AND PLATELETS (PLT) RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9500555 ↗
• MalfunctionNov 7, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS AT A CUSTOMER SITE AND REPORTED THAT A SAMPLE BARCODE WAS MISREAD ON AN ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER BY THE SYSTEM'S HAND HELD BARCODE READER. PATIENT SAMPLE IDENTIFICATION NUMBER (SID) (B)(6) WAS MISREAD AS SID (B)(6). THE ERROR WAS FOUND BY THE CUSTOMER AND THE INITIAL PATIENT RESULTS WERE NOT RELEASED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9293462 ↗
• MalfunctionNov 1, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS AT A CUSTOMER SITE AND REPORTED THAT A SAMPLE BARCODE WAS MISREAD ON AN ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER BY THE SYSTEM'S HAND HELD BARCODE READER DURING A MANUAL SAMPLE BARCODE READ. SID (B)(6) WAS MISREAD AS SID (B)(6). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9266499 ↗
• MalfunctionAug 8, 2019Use of Device Problem; Use of Device Problem

  A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) SUSTAINED A NEEDLESTICK INJURY WHILE THE CSE PERFORMED SERVICE ON A CENTERING COLLAR ON AN ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER. THE WOUND WAS CLEANED. THERE ARE NO KNOWN REPORTS OF MEDICAL INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8875973 ↗
• MalfunctionApr 11, 2019Use of Device Problem; Use of Device Problem

  A CUSTOMER REPORTED THAT A DROP OF BLOOD FROM THE ASPIRATION TUBE SPLASHED INTO THE OPERATOR'S EYE WHILE THEY WERE REMOVING A SAMPLE IN OPEN MODE ON AN ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER (SN: (B)(4)). THE OPERATOR WENT TO THEIR OCCUPATIONAL HEALTH DEPARTMENT, FLUSHED THE EYE AND HAD BLOOD DRAWN FOR BASELINE BLOOD TESTS. THE OPERATOR WAS TESTED FOR INFECTIOUS DISEASES ((B)(6)) AND THE RESULTS REPORTED WERE (B)(6) FOR BOTH. THERE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DROP OF BLOOD SPLASHED IN THE OPERATOR'S EYE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8504369 ↗
• MalfunctionMar 28, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  DISCORDANT RED BLOOD CELL (RBC) COUNT AND PLATELET (PLT) RESULTS WERE OBTAINED ON A PATIENT SAMPLE(S) USING AN ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE CUSTOMER PERFORMED REPEAT TESTING USING A NON-SIEMENS INSTRUMENT. THE REPEAT RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RBC AND PLT RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8460914 ↗
• MalfunctionJan 7, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT ON (B)(6) 2018, A DISCORDANT, FALSELY ELEVATED HEMOGLOBIN (HGB) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. ON THE NEXT DAY, THE PATIENT WAS REDRAWN AND THE NEW SAMPLE WAS RUN ON THE SAME SYSTEM, RESULTING LOWER. THE INITIAL SAMPLE WAS REPEATED ON THE SAME SYSTEM, RESULTING SIMILAR TO THE RESULT OBTAINED ON THE REDRAWN SAMPLE. THE HGB RESULT OF 8.9 G/DL WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). OTHER PARAMETERS OF THE COMPLETE BLOOD COUNT (CBC), INCLUDING THE RED BLOOD CELL COUNT, PLATELET COUNT AND WHITE BLOOD CELL COUNT, WERE IMPACTED BY THIS ISSUE. HOWEVER, THE CORRECT RESULTS FOR THE OTHER PARAMETERS ARE UNKNOWN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DIFFERENT RESULTS OBTAINED ON THE OTHER PARAMETERS OF THE CBC.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8222359 ↗
• MalfunctionJan 7, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT A DISCORDANT, FALSELY ELEVATED HEMOGLOBIN (HGB) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. ON THE NEXT DAY, THE PATIENT WAS REDRAWN AND THE NEW SAMPLE WAS RUN ON THE SAME SYSTEM, RESULTING LOWER. THE INITIAL SAMPLE WAS REPEATED ON THE SAME SYSTEM, RESULTING SIMILAR TO THE RESULT OBTAINED ON THE REDRAWN SAMPLE. THE HGB RESULT OF 8.9 G/DL WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). OTHER PARAMETERS OF THE COMPLETE BLOOD COUNT (CBC), INCLUDING THE RED BLOOD CELL COUNT, PLATELET COUNT AND WHITE BLOOD CELL COUNT, WERE IMPACTED BY THIS ISSUE. HOWEVER, THE CORRECT RESULTS FOR THE OTHER PARAMETERS ARE UNKNOWN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED HGB RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8222358 ↗
• MalfunctionNov 28, 2018Device Handling Problem; Device Handling Problem

  THE CUSTOMER REPORTED THAT AN OPERATOR SUSTAINED A NEEDLESTICK INJURY TO THE HAND WHEN PERFORMING MAINTENANCE ON AN ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER. THE OPERATOR STUBBED AND SCRATCHED HER HAND WITH THE AUTOSAMPLER NEEDLE WHILE REMOVING THE CENTERING COLLAR. THE CUSTOMER REPORTED THAT THE OPERATOR RECEIVED NECESSARY MEDICAL CARE, BUT DID NOT PROVIDE FURTHER DETAILS REGARDING THE MEDICAL TREATMENT ADMINISTERED TO THE OPERATOR. THE CUSTOMER ALLEGED THAT SINCE A(B)(6)SAMPLE WAS RUN ON THE SYSTEM, THE OPERATOR UNDERWENT (B)(6) RELATED TESTS. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE OPERATOR SUSTAINING A NEEDLESTICK INJURY WHILE PERFORMING MAINTENANCE ON THE ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER.

  Patient problems: Needle Stick/Puncture

  MAUDE report 8113151 ↗
• MalfunctionNov 20, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT A DISCORDANT, FALSELY LOW WHITE BLOOD CELL COUNT (WBC) RESULT OF 5.40 X 10E3/UL WAS OBTAINED ON A PATIENT SAMPLE ON AN ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED ON TWO ALTERNATE ADVIA 2120I HEMATOLOGY SYSTEMS WITH DUAL ASPIRATE, RESULTING HIGHER. THE CUSTOMER REPORTED THAT THE CORRECT RESULT WAS REPORTED TO THE PHYSICIAN(S), BUT DID NOT INDICATE WHICH RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW WBC RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8089872 ↗
• MalfunctionJul 9, 2018Mechanical Problem; Mechanical Problem

  WHILE TROUBLESHOOTING THE CLOGGED UNIFIED FLUIDS CIRCUIT (UFC) PATHWAY ON AN ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER, A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS SPLASHED IN THE EYE WITH BLEACH. THE CSE RINSED HIS EYE WITH WATER AND DID NOT SEEK ADDITIONAL MEDICAL INTERVENTION OR TREATMENT. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE BLEACH THAT SPLASHED INTO THE CSE'S EYE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7669194 ↗
• MalfunctionApr 12, 2018Device Handling Problem; Device Handling Problem

  THE CUSTOMER REPORTED THAT A CLOT WAS PRESENT IN THE CENTERING COLLAR ON THE ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER. THEY ALSO REPORTED THAT THERE WAS LEAKAGE NEAR THE CENTERING COLLAR. UPON PERFORMING MAINTENANCE ON THE CENTERING COLLAR, THE CUSTOMER SUSTAINED A NEEDLESTICK INJURY TO THE FINGER. THE CUSTOMER DID NOT REQUIRE MEDICAL INTERVENTION AND WAS TESTED FOR INFECTIOUS DISEASES, WHICH RECOVERED AS NEGATIVE. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE CUSTOMER SUSTAINING A NEEDLESTICK INJURY WHILE PERFORMING MAINTENANCE THE CENTERING COLLAR ON THE ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7427202 ↗
• MalfunctionMar 27, 2018Mechanical Problem; Mechanical Problem

  A PATIENT SAMPLE WAS RUN ON THE ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER, RESULTING IN A HEMOGLOBIN (HGB) RESULT OF 1.7 G/DL. THE CUSTOMER INDICATED THAT PRIOR TO RUNNING THIS SAMPLE, THE HEMOGLOBIN QUALITY CONTROL (QC) RECOVERY WAS WITHIN EXPECTED RANGE AND THE NEUTY GAINS WERE ELEVATED. THE CUSTOMER SUSPECTED A SYSTEM MALFUNCTION AND DID NOT REPORT THE HGB RESULT. THE CUSTOMER ALSO REPORTED THAT THEY RERAN QC AFTER OBTAINING THE INITIAL HGB RESULT; THE HBG QC RECOVERED OUT OF RANGE AND THE CUSTOMER OBSERVED ERRORS WITH RED BLOOD CELL (RBC) AND HGB. THE CUSTOMER REQUESTED A NEW SAMPLE FROM THE PATIENT. AFTER TROUBLESHOOTING, THE INSTRUMENT WITH A SIEMENS CUSTOMER SERVICE ENGINEER (CSE), THE CUSTOMER RAN A NEW SAMPLE FROM THE PATIENT, WHICH RESULTED 1.7 G/DL AS THE INITIAL RESULT. THE CUSTOMER STATED THAT WHEN THEY ATTEMPTED TO REPORT THE HGB RESULT TO THE PHYSICIAN(S), THEY WERE ALERTED THAT THE PATIENT EXPIRED. THE CUSTOMER STATED THE DELAY IN REPORTING THE COMPLETE BLOOD COUNT (CBC) ON THIS PATIENT SAMPLE DELAYED THE PATIENT'S BLOOD TRANSFUSION. STATEMENTS ATTRIBUTED TO THE PHYSICIAN AND CUSTOMER ARE DERIVED FROM INFORMATION SUBMITTED TO SIEMENS COMPLAINT HAN

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7375000 ↗
• MalfunctionFeb 16, 2018Low Test Results; Low Test Results

  A PATIENT SAMPLE WAS TESTED ON THE ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER, RESULTING IN AN EXPECTED HEMOGLOBIN (HGB) RESULT. THIS RESULT WAS REPORTED TO THE PHYSICIAN(S). THE CUSTOMER STOPPED THE ROUTINE TESTING OF THE AUTOSAMPLER TO TEST A STAT SAMPLE MANUALLY. UPON COMPLETION OF THE STAT SAMPLE RUN, THE OPERATOR RESUMED THE AUTOSAMPLER'S OPERATION AND THE AUTOSAMPLER RERAN THE INITIAL SAMPLE, WHICH RESULTED IN A LOWER HGB RESULT. THE OPERATOR INDICATED THAT THE AUTOSAMPLER PIERCED THE SAMPLE, WITHOUT MIXING, AND QUESTIONED THE RESULT. THE SAMPLE WAS RERUN, ON THE SAME SYSTEM, RESULTING IN A DISCORDANT, FALSELY LOW HGB RESULT. THE SAME SAMPLE WAS RERUN ON A NON-SIEMENS, SYSMEX KX-21 SYSTEM, RESULTING IN A SIMILAR HGB RESULT AS THE DISCORDANT RESULT. THE OPERATOR ALSO PERFORMED A MANUAL SMEAR AND STAIN, USING THE SAME SAMPLE, AND DETERMINED THAT THE NEUTROPHIL'S MEMBRANES WERE AFFECTED. OTHER PARAMETERS IN THE COMPLETED BLOOD COUNT (CBC) WERE POTENTIALLY IMPACTED BY THIS EVENT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW HGB RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7277285 ↗
• MalfunctionOct 25, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DISCORDANT, FALSELY LOW HEMOGLOBIN (HGB) RESULTS WERE ONLY OBTAINED ON THE ADVIA 2120I HEMATOLOGY SYSTEM WITH SERIAL NUMBER (SN) (B)(4) FOR THE PATIENT SAMPLE. THERE WERE NO REPORTS OF DISCORDANT HGB RESULTS OBTAINED ON THE ADVIA 2120I HEMATOLOGY SYSTEM WITH SN (B)(4) FOR THIS SAMPLE. THE PATIENT'S BLOOD WAS REDRAWN AND RUN AT AN ALTERNATE LABORATORY ON A NON-SIEMENS (SYSMEX) SYSTEM, RESULTING IN A HIGHER HGB RESULT. A CORRECTED REPORT WAS PROVIDED TO THE PHYSICIAN. BASED ON THE PATIENT'S CLINICAL HISTORY, THE CORRECT HGB RESULT FOR THIS PATIENT WAS APPROXIMATELY 7.0 G/DL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6976761 ↗
• MalfunctionOct 25, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE AFFECTED PATIENT SAMPLE WAS RUN ON BOTH ADVIA 2120I HEMATOLOGY SYSTEMS AND WAS NOT REPEATED ON EITHER SYSTEM. THE HEMOGLOBIN (HGB) RESULT OF 6.3 G/DL WAS NOT OBTAINED ON THE ADVIA 2120I HEMATOLOGY SYSTEM WITH SERIAL NUMBER (SN) (B)(4). THE PATIENT'S BLOOD WAS REDRAWN AND RUN AT AN ALTERNATE LABORATORY ON A NON-SIEMENS ((B)(4)) SYSTEM, RESULTING IN A HGB RESULT OF 7.8 G/DL. THE CORRECT HGB RESULT FOR THIS PATIENT IS EITHER 7.5 G/DL OR 7.8 G/DL. A CORRECTED REPORT WAS PROVIDED TO THE PHYSICIAN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6976760 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K102644. One submission often covers many models, so check the product and lot details in each record.

• Z-1401-2021 · Mar 5, 2021 · Open, Classified
  ADVIA 2120i Dual Aspirate Autosampler (SMN 10285573) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
• Z-1392-2021 · Mar 5, 2021 · Open, Classified
  ADVIA 2120i Refurb Single Aspirate (SMN 11314044) - US, automated hematology analyzer Software Versions 6.10 and 6.11
• Z-1398-2021 · Mar 5, 2021 · Open, Classified
  ADVIA 2120 REFURB SAA AUTOSAMPLER (SMN 10374453) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
• Z-1393-2021 · Mar 5, 2021 · Open, Classified
  ADVIA 2120i Refurb Dual Aspirate (SMN 11314045) - US, automated hematology analyzer Software Versions 6.10 and 6.11
• Z-1400-2021 · Mar 5, 2021 · Open, Classified
  ADVIA 2120i with Single Aspirate Autosampler (SMN 10488923) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
• Z-1394-2021 · Mar 5, 2021 · Open, Classified
  ADVIA 2120i (RoHS) with Single Aspirate Autosampler (SMN 11219529) - US, automated hematology analyzer Software Versions 6.10 and 6.11
• Z-1386-2021 · Mar 5, 2021 · Open, Classified
  ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - US, automated hematology analyzer Software Versions 6.10 and 6.11
• Z-1389-2021 · Mar 5, 2021 · Open, Classified
  ADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) - US, automated hematology analyzer Software Versions 6.10 and 6.11
• Z-1396-2021 · Mar 5, 2021 · Open, Classified
  ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
• Z-1405-2021 · Mar 5, 2021 · Open, Classified
  ADVIA 2120i (RoHS) Dual Aspirate Autosampler (SMN 11219530) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
• Z-1403-2021 · Mar 5, 2021 · Open, Classified
  ADVIA 2120i Refurb Dual Aspirate (SMN 11314045) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
• Z-1397-2021 · Mar 5, 2021 · Open, Classified
  ADVIA 2120 Dual Aspirate Autosampler (SMN 10313419) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
• Z-1404-2021 · Mar 5, 2021 · Open, Classified
  ADVIA 2120i (RoHS) with Single Aspirate Autosampler (SMN 11219529) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
• Z-1399-2021 · Mar 5, 2021 · Open, Classified
  ADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
• Z-1402-2021 · Mar 5, 2021 · Open, Classified
  ADVIA 2120i Refurb Single Aspirate (SMN 11314044) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11

…and 5 more.