RAPIDPoint® 500 System 10492730Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00630414589169), received between Jun 23, 2017 and Mar 14, 2024 — classified as 1 death, 31 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (8 reports).

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

11 other recalls cover devices cleared under the same FDA submission (K113216); 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 16, 2026.

Recalls naming this device

1. Sep 26, 2023Open, Classified

   There are potential drug interferences from Perhexiline Maleate or Atomoxetine Hydrochloride that may cause falsely elevated sodium results reported on the RAPIDPoint 500 and RAPIDPoint 500e Blood Gas Systems. The erroneous sodium levels with positive bias may lead to unrecognized hyponatremia and/or the inappropriate treatment of hypernatremia may lead to iatrogenic hyponatremia, resulted in a delay in patient diagnosis and optimal patient management.

   Z-0423-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 14, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE CUSTOMER REPORTED THAT THE INCORRECT PATIENT ID WAS SELECTED 13 TIMES DURING AN OPEN-HEART PROCEDURE. THE OPERATOR INCORRECTLY ATTEMPTED TO USE THE "PREVIOUS PATIENT" FEATURE. THE RESULTS WERE SENT TO THE INCORRECT PATIENT CHART. THE ERROR WAS IDENTIFIED AND THE RESULTS WERE EDITED AND TRANSFERRED TO THE CORRECT PATIENT CHART. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18907095 ↗
• MalfunctionSep 19, 2023Overheating of Device; Overheating of Device

  CUSTOMER STATED THAT THEY SAW SMOKE COMING FROM THEIR RP500 INSTRUMENT WHILE IN USE. THE INSTRUMENT WAS THEN SHUT DOWN AND UNPLUGGED. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17773782 ↗
• MalfunctionJan 25, 2023Low Test Results; Low Test Results

  THE CUSTOMER REPORTED A DISCREPANT LACTATE RESULT COMPARED TO RETESTING OF A DIFFERENT SAMPLE ON A NON-SIEMENS LAB INSTRUMENT. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16240080 ↗
• MalfunctionNov 2, 2020Non Reproducible Results; Non Reproducible Results

  THE CUSTOMER REPORTED DISCREPANT LOW SODIUM RESULTS ON TWO PATIENTS RUN ON THE RP 500 WHEN COMPARED TO A NON-SIEMENS LAB INSTRUMENT. THE CUSTOMER STATED THAT BOTH PATIENTS HAD DELAYED OR PROCEDURES DUE TO THE LOW RESULTS. PATIENT #1, DELAYED PROCEDURE: LAPAROSCOPIC PERITONEAL DIALYSIS CATHETER WITH REMOTE EXTENSION WITH EXIT ON CHEST. PATIENT #2, DELAYED PROCEDURE: TRANSURETHRAL RESECTION OF BLADDER TUMOR. BOTH PROCEDURES WERE DELAYED FOR APPROXIMATELY ONE HOUR. THERE WAS NO INJURY TO THE PATIENTS DUE TO THIS EVENT.

  Patient problems: Increased Intra-Peritoneal Volume (IIPV); Renal Impairment

  MAUDE report 10775055 ↗
• MalfunctionOct 29, 2020Use of Device Problem; Use of Device Problem

  THE CUSTOMER STATES THAT AN ORDER WAS CREATED UNDER THE WRONG PATIENT WHICH DELIVERED BLOOD GAS RESULTS INTO THE WRONG PATIENT'S CHART IN LIS. CUSTOMER STATES THAT BOTH PATIENTS HAVE THE SAME LAST NAME AND CONFIRMS THAT BLOOD WAS DRAWN AND COLLECTED FROM THE INTENDED, CORRECT PATIENT. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10756320 ↗
• MalfunctionSep 30, 2020Use of Device Problem; Use of Device Problem

  THE CUSTOMER REPORTED THAT THE OPERATOR STATES THAT HE TRIED TO REPLACE A MEASUREMENT CARTRIDGE IN THE RP 500 AND NOTICED A DOOR ERROR AND ELECTRONIC ERROR. HE THEN TRIED TO PUSH THE DOOR SHUT AND NOTICED HIS RIGHT HAND, INDEX FINGER, PUNCTURED THE SAMPLE PORT NEEDLE. HE IMMEDIATELY BLED OUT THE CUT AND FOLLOWED OCCUPATIONAL HEALTH PROCEDURES AND POLICIES AND WENT TO THE ER TO GET TREATED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 10609889 ↗
• MalfunctionAug 26, 2020Non Reproducible Results; Non Reproducible Results

  THE CUSTOMER REPORTED DISCREPANT THB RESULTS FROM THEIR RP500 INSTRUMENT COMPARED TO RETESTING OF THE SAME SAMPLES ON A NON SIEMENS INSTRUMENT. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10454504 ↗
• MalfunctionApr 21, 2020Non Reproducible Results; Non Reproducible Results

  THE CUSTOMER REPORTED DISCREPANT LOW PCO2 RESULTS RUN ON AN RP 500 INSTRUMENT WHEN COMPARED TO ANOTHER RP 500 INSTRUMENT. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9983156 ↗
• MalfunctionMar 17, 2020Computer Software Problem; Computer Software Problem

  THE CUSTOMER REPORTED THEY RAN A PATIENT ON THE RP 500 AND THE USER CONFIRMS THE PATIENT ID WAS SCANNED CORRECTLY, ALL RESULTS ON THE PATIENT'S CHART ARE CORRECT, THE PRINTOUTS FROM THE ANALYZER ARE CORRECT AND THE RAPIDCOMM RESULTS ARE CORRECT. WHEN THE USER RECALLED THE PATIENT LIST, SEVERAL RESULTS FROM THE PREVIOUS 24 HOURS WERE ALL OVERWRITTEN WITH ONE, DIFFERENT PATIENT ID. THERE WAS NO REPORT OF INJURY DUE TO THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9844902 ↗
• MalfunctionMar 16, 2020Computer Software Problem; Computer Software Problem

  THE CUSTOMER REPORTED THE PATIENT IDS ON THE RP 500 S/N (B)(4) ARE BEING OVERWRITTEN WITH A DIFFERENT NUMBER AFTER MEASUREMENT. THE CUSTOMER STATED THE INITIAL PRINTOUTS ARE CORRECT. WHEN THE OPERATOR GOES INTO THE RECALL SCREEN THERE IS ANOTHER PATIENT ID FOR THAT SAMPLE. THEN WHEN SHE LOOKS IN RAPIDCOMM THERE IS A DIFFERENT PATIENT ID. THE CUSTOMER HAS 11 ANALYZERS. IT WAS VERIFIED THAT THE RP 500 S/N (B)(4) IS THE ONLY ANALYZER IMPACTED. THIS ANALYZER IS IN THE OR. THE CUSTOMER STATED THEY USE THE PRINTOUT IN THE OPERATING ROOM, SO THE CORRECT RESULT WAS ALWAYS PROVIDED TO THE PHYSICIAN. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9835942 ↗
• MalfunctionOct 18, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER REPORTED SOME SMOKE WAS COMING FROM THE RP 500. THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9211084 ↗
• MalfunctionSep 25, 2019Non Reproducible Results; Non Reproducible Results

  THE CUSTOMER REPORTED DISCREPANT TOTAL HEMOGLOBIN RESULTS ON THE RP 500 AND WHEN COMPARED TO A NON-SIEMENS HEMATOLOGY ANALYZER. THERE WAS NO REPORT OF HARM DUE TO THIS EVENT.

  Patient problems: Abnormal Blood Gases

  MAUDE report 9120043 ↗
• MalfunctionJul 12, 2019Non Reproducible Results; Non Reproducible Results

  THE CUSTOMER REPORTED DISCREPANT TOTAL HEMOGLOBIN RESULTS ON THE RP 500 WHEN COMPARED TO A NON-SIEMENS HEMATOLOGY ANALYZER. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8785516 ↗
• MalfunctionApr 30, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER REPORTED THAT ON THE RP 500, THE HARD DRIVE WIRING HARNESS MELTED, PRODUCING SMOKE. THERE WAS NO VISIBLE FLAMES OR EXPOSURE. THERE WAS NO REPORT OF HARM TO ANY OPERATOR OR PATIENTS.

  Patient problems: No Patient Involvement

  MAUDE report 8566946 ↗
• MalfunctionApr 24, 2019Non Reproducible Results; Non Reproducible Results

  THE CUSTOMER REPORTED A DISCREPANT TOTAL HEMOGLOBIN RUN ON THE RP 500 WHEN COMPARED TO A NON-SIEMENS LAB ANALYZER AND ANOTHER RP 500. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8545046 ↗
• DeathJan 3, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE CUSTOMER REPORTED A DISCREPANT POTASSIUM RESULT RUN ON THE RP 500 S/N (B)(4) WHEN COMPARED TO RESULTS ON A NON-SIEMENS LAB ANALYZER, ON A CODE PATIENT WHO CAME INTO THE MEDICAL CENTER. THE PATIENT HAS KIDNEY FAILURE BUT HAD NOT RECEIVED DIALYSIS AND THEY WERE EXPECTING HYPERKALEMIA. THE PATIENT WAS GIVEN CALCIUM FOR CARDIAC SUPPORT. A SAMPLE WAS DRAWN FROM A LINE INTO A LITHIUM HEPARIN VACUUM TUBE AND WAS RUN ON THE NON-SIEMENS LAB ANALYZER AT 10:25. THE PATIENT WAS GIVEN INSULIN AND ALBUTEROL. A FEMORAL ARTERY SAMPLE WAS RUN ON THE RP 500 AT 10:38. THIS SAME FEMORAL ARTERY SAMPLE WAS RUN ON THE NON-SIEMENS LAB ANALYZER AT 14:40. THE CUSTOMER WAS ASKED IF AN ADDITIONAL SAMPLE WAS DRAWN FROM THE PATIENT AND SHE STATED THAT NO ADDITIONAL BLOOD WAS DRAWN BECAUSE THE PATIENT HAD DIED. THERE IS NO ALLEGED HARM TO THE PATIENT OR USER DUE TO THE USE OF THE RP 500.

  Patient problems: Abnormal Blood Gases

  MAUDE report 8213400 ↗
• MalfunctionAug 22, 2018Incorrect, Inadequate or Imprecise Result or Readings; Insufficient Device Problem Information; Insufficient Device Problem Information

  THE CUSTOMER REPORTED DISCREPANT TOTAL HEMOGLOBIN RESULTS ON THE RP 500 COMPARED TO A NON-SIEMENS LAB ANALYZER. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7805074 ↗
• MalfunctionAug 9, 2018Incorrect, Inadequate or Imprecise Result or Readings; Use of Device Problem; Use of Device Problem

  THE CUSTOMER REPORTED DISCREPANT HIGH SODIUM RESULTS ON THE RP 500. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7770167 ↗
• MalfunctionAug 7, 2018Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED DISCREPANT SODIUM RESULTS ON THE RP 500 COMPARED TO ANOTHER SIEMENS LAB ANALYZER. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7756457 ↗
• MalfunctionAug 1, 2018Incorrect, Inadequate or Imprecise Result or Readings; Use of Device Problem; Use of Device Problem

  THE CUSTOMER REPORTED DISCREPANT SODIUM RESULTS ON TWO RP 500 INSTRUMENTS. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7739596 ↗
• MalfunctionJun 29, 2018Patient Data Problem

  THE CUSTOMER REPORTED THAT THE INFORMATION IN THE CUSTOM DEMOGRAPHIC MODE FIELD WAS DIFFERENT FROM THE ORIGINAL PRINTOUT WHEN REPRINTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7651265 ↗
• MalfunctionJun 26, 2018Incorrect Or Inadequate Test Results

  THE CUSTOMER REPORTED DISCREPANT TOTAL HEMOGLOBIN RESULTS RUN ON THE RP 500 AND A NON-SIEMENS CHEMISTRY LAB ANALYZER. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7638799 ↗
• MalfunctionJun 15, 2018Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT AN ANESTHESIOLOGIST WAS QUESTIONING A SODIUM RESULT ON THE RP 500 (S/N (B)(4)) DURING A LIVER TRANSPLANT. A TOTAL OF 23 BLOOD GASES WERE RUN DURING THE PROCEDURE. THE SODIUM VALUES WERE ALL IN THE RANGE OF 119 - 124 MMOL/L EXCEPT FOR ONE QUESTIONABLE RESULT WHICH WAS 137 MMOL/L. THE ANESTHESIOLOGIST ASKED FOR ANOTHER RP 500 (S/N (B)(4)) TO BE BROUGHT TO THE OPERATING ROOM. THE SECOND RP 500 (S/N (B)(4)) WAS USED FOR THE REMAINDER OF THE PROCEDURE. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7604961 ↗
• MalfunctionMar 21, 2018Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED DISCREPANT PH RESULTS BETWEEN CAPILLARY AND ARTERIAL SAMPLES RUN ON TWO RP 500S. THE CAPILLARY SAMPLES FROM (B)(6) 2018 DID NOT MATCH THE BABY'S APPEARANCE OR CONDITION. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7357992 ↗
• MalfunctionFeb 5, 2018Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED DISCREPANT GLUCOSE VALUES ON TWO DIFFERENT RP 500 ANALYZERS. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7241642 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113216. One submission often covers many models, so check the product and lot details in each record.

• Z-2040-2017 · Apr 10, 2017 · Terminated
  RAPIDPoint 500 Blood Gas Analyzer with v2.4 software for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, to
• Z-2799-2016 · Aug 11, 2016 · Terminated
  Siemens RAPIDPoint 500 Blood Gas Analyzer Siemens Material Number (SMN): 10492730, 10696855, 10696857, 10697306
• Z-2601-2016 · Jul 5, 2016 · Terminated
  Siemens RAPIDPoint 500 v2.2.2A Software Upgrade Kit; SMN 11066719, Software Version 2.2A The RAPIDPoint 500 system is designed for professional use in a point-of care or laboratory
• Z-2813-2015 · Aug 24, 2015 · Terminated
  Siemens RAPIDPoint 500 Measurement Cartridge Lactate (750 tests) Part Number: 10491449 Product Usage: The RAPIDPoint 500 system is designed for professional use in a point-of-care
• Z-2816-2015 · Aug 24, 2015 · Terminated
  Siemens RAPIDPoint 500 Measurement Cartridge Lactate (100) tests Part Number: 10844813 Product Usage: The RAPIDPoint 500 system is designed for professional use in a point-of-care
• Z-2815-2015 · Aug 24, 2015 · Terminated
  Siemens RAPIDPoint 500 Measurement Cartridge Lactate (250) tests Part Number: 10491447 Product Usage: The RAPIDPoint 500 system is designed for professional use in a point-of-care
• Z-2814-2015 · Aug 24, 2015 · Terminated
  Siemens RAPIDPoint 500 Measurement Cartridge Lactate (400) tests Part Number: 10491448 Product Usage: The RAPIDPoint 500 system is designed for professional use in a point-of-care
• Z-2479-2015 · Jul 28, 2015 · Terminated
  RAPIDPoint 500 Blood Gas Analyzer, Siemens Material Numbers (SMN):10492730, 10696855, 10696857, 10697306 This system tests blood gases, electrolytes, metabolites, total hemoglobi
• Z-1253-2015 · Dec 30, 2014 · Terminated
  RAPIDPoint 500 Blood Gas Analyzer; Siemens Material Number: 10492730, 10696855, 10696857, 10697306. The RAPIDPoint 500 system is designed for professional use in a point-of-care
• Z-2079-2014 · May 23, 2014 · Terminated
  RAPIDPoint 500 Measurement Clinical Chemistry System RAPIDPoint 500 Measurement Cartridge Lactate (750 Tests) Part number: 10491449; RAPIDPoint 500 Measurement Cartridge Lactate (4
• Z-0104-2014 · Sep 17, 2012 · Terminated
  Siemens RAPIDPoint 500 system blood gas analyzer Product Usage: RAPIDPoint 500 System: The RAPIDPoint 500 system is designed for professional use in a point-of-care or laboratory