RAPIDPoint® 500e Blood Gas System 11416751Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00630414286143), received between May 21, 2020 and Apr 20, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “No Device Output” (2 reports).

2 FDA recall records name this device's identifier, 2 still open.

2 other recalls cover devices cleared under the same FDA submission (K192240); 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. May 17, 2024Class IIOpen, Classified

   Siemens Healthineers has identified an issue with the RAPIDPoint500e system software version 5.3. This issue affects how the sample source is identified at the LIS when using the capillary mode. With this software version, samples run in the capillary mode are incorrectly labeled as arterial when displayed on the LIS, leading to the potential for results to be flagged according to an established arterial range. Capillary sample results are correctly identified as capillary on both the RAPIDPoint 500e system display and the instrument printouts. The issue only affects the new software version 5.3 and only capillary sample mode is impacted. The inability to distinguish specimen sources for blood gas may lead to incorrect diagnoses and management decisions.

   Z-2214-2024 · Root cause: Software Design Change · Recall details · FDA record ↗

2. Sep 26, 2023Class IIOpen, 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-0422-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 20, 2026Patient Data Problem

  CUSTOMER REPORTED THAT THEIR INSTRUMENT REVERTED BACK TO THE PREVIOUS PATIENT'S INFORMATION/DEMOGRAPHICS WHEN USER/OPERATOR SCANNED PATIENT BARCODE AND RAN THE PATIENT SAMPLE. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24930571 ↗
• MalfunctionMay 29, 2025Use of Device Problem; Use of Device Problem

  THE CUSTOMER REPORTED THAT ON (B)(6) 2025 @ 18:06 A BARCODE LABEL WAS PRINTED FOR A PATIENT (ID: (B)(6) WHO WAS REGISTERED IN THE HOSPITAL SYSTEM BUT WAS NOT AN INPATIENT. THE LABEL WAS PLACED ON A SAMPLE FOR AN INPATIENT (ID: (B)(6). THE ISSUE WAS DISCOVERED BY THE PHYSICIAN AS THERE WERE NO RESULTS IN THE INPATIENT'S CHART BECAUSE RESULTS WERE TRANSFERRED TO WRONG PATIENT. ACCOUNT NUMBERS: (B)(6) (NOT INPATIENT), (B)(6) (INPATIENT). THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22104012 ↗
• MalfunctionApr 21, 2025Patient Data Problem; Patient Data Problem

  THE CUSTOMER REPORTED THAT THE INSTRUMENT IS NOT SAVING THE LAST NAME DEMOGRAPHICS WHEN DATA IS ENTERED AND DOES NOT SHOW ON THE TEST RECORD CORRECTLY. THE CUSTOMER STATES THAT THE LAST NAME IS FROM A PREVIOUS TEST. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21873306 ↗
• MalfunctionAug 23, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT THEY RECEIVED A DISCREPANT HCO3 RESULT (WHICH IS CALCULATED FROM PCO2 AND PH) ON ONE PATIENT COMPARED TO RETESTING OF DIFFERENT SAMPLES ON THE SAME INSTRUMENT AND ANOTHER RP500E INSTRUMENT. CUSTOMER STATED THAT THE PATIENT'S VENTILATOR SETTINGS WERE ADJUSTED BASED ON THE INCORRECT RESULTS BUT THAT THERE WAS NO HARM AND PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20048668 ↗
• MalfunctionFeb 18, 2022No Device Output; No Device Output

  THE CUSTOMER REPORTED THAT THE PATIENT SAMPLE CLOTTED THEIR (B)(4) ANALYZER AND THEREFORE A BLOOD GAS RESULT COULD NOT BE OBTAINED DURING A CODE. THE PATIENT DIED. SAFETY DATA INFORMATION FROM THE COMPLAINT STATES THAT THE CUSTOMER IS NOT ALLEGING THAT THE CAUSE WAS RELATED TO AN INSTRUMENT MALFUNCTION OR HARM TO THE PATIENT WAS DUE TO THE USE OF THE DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 13563737 ↗
• MalfunctionFeb 18, 2022No Device Output; No Device Output

  THE CUSTOMER REPORTED THAT THE PATIENT SAMPLE CLOTTED THEIR RP500E ANALYZER AND THEREFORE A BLOOD GAS RESULT COULD NOT BE OBTAINED DURING A CODE. THE PATIENT DIED. SAFETY DATA INFORMATION FROM THE COMPLAINT STATES THAT THE CUSTOMER IS NOT ALLEGING THAT THE CAUSE WAS RELATED TO AN INSTRUMENT MALFUNCTION OR HARM TO THE PATIENT WAS DUE TO THE USE OF THE DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 13563733 ↗
• MalfunctionMay 21, 2020Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  INTERNAL TESTING HAS DETERMINED THAT THE RP500E EXTERNAL BARCODE SCANNER MODEL DS4308 DOES NOT OPERATE AS INTENDED WHEN USING CODE 39 WITH CHECK DIGIT ENABLED BARCODES. THERE IS A REMOTE POSSIBILITY OF INCORRECT IDENTIFICATION OF PATIENT RESULTS BY THE MEDICAL DEVICE WHEN USING THIS BARCODE SCANNER TO SCAN PATIENT IDS WITH THE INDICATED SYMBOLOGY. THERE HAVE BEEN NO REPORTS OF INJURY DUE TO THIS DEFECT FROM CUSTOMERS.

  Patient problems: No Patient Involvement

  MAUDE report 10080026 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K192240. One submission often covers many models, so check the product and lot details in each record.

• Z-1372-2022 · Jun 1, 2022 · Open, Classified
  epoc BGEM Test Card 25 Test Cards/box. In vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole b
• Z-2432-2020 · May 27, 2020 · Terminated
  RP500e Handheld Barcode Scanner, Zebra Model: DS4308 - HC0062BZZWW, Siemens Material Number (SMN) 11416778