Dexcom G4 Platinum Professional Receiver Kit STK-PU-001Recalls & reported problems
Dexcom, Inc. · G4 Platinum Professional Receiver Kit · Class 3
All models of Dexcom G4 Platinum (41)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Dexcom G4 Platinum receiver has 423 reports, all of them malfunctions, with no deaths and no injuries. Common problems described include wireless connection failures, wrong messages on the screen, and the receiver failing to show readings or sound its alarm. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 423
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 423 adverse event reports that list this exact device (DI 40386270000062), received between May 5, 2016 and Mar 30, 2020 — classified as 423 malfunctions.
The most frequently reported specific device problem is “Wireless Communication Problem” (152 reports).
2 other recalls cover devices cleared under the same FDA submission (P120005); 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.
Most reported problems
Device problems
- Wireless Communication Problem152
- Device Displays Incorrect Message121
- Unable to Obtain Readings34
- No Audible Alarm32
- Defective Alarm30
- Inappropriate or Unexpected Reset21
- Device Inoperable12
- Device Operates Differently Than Expected9
Patient problems
- No Consequences Or Impact To Patient416
- No Known Impact Or Consequence To Patient6
- Hypoglycemia1
Recent adverse event reports
The 25 most recent of 423 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 30, 2020Unable to Obtain Readings; Unable to Obtain Readings
IT WAS REPORTED THAT ERROR ICON DISPLAYED OCCURRED. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9901504 ↗MalfunctionFeb 24, 2020Unable to Obtain Readings; Unable to Obtain Readings
IT WAS REPORTED THAT ERROR ICON DISPLAYED OCCURRED. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9747886 ↗MalfunctionFeb 4, 2020Unexpected Shutdown; Unexpected Shutdown
IT WAS REPORTED THAT UNEXPECTED RECEIVER SHUTDOWN OCCURRED. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9664246 ↗MalfunctionNov 26, 2019Unable to Obtain Readings; Unable to Obtain Readings
IT WAS REPORTED THAT THE RECEIVER DISPLAYED ERR CALL TECH SUPPORT OCCURRED . NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE ALLEGATION AND A ROOT CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9377764 ↗MalfunctionNov 22, 2019Unable to Obtain Readings; Unable to Obtain Readings
IT WAS REPORTED THAT THE RECEIVER DISPLAYED ERR HWBBT OCCURRED. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE ALLEGATION AND A ROOT CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9365049 ↗MalfunctionNov 22, 2019Unable to Obtain Readings; Unable to Obtain Readings
IT WAS REPORTED THAT THE RECEIVER DISPLAYED ERR HWRF OCCURRED . NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE ALLEGATION AND A ROOT CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9365040 ↗MalfunctionNov 12, 2019No Audible Alarm; No Audible Alarm
IT WAS REPORTED THAT THE RECEIVER HAD NO AUDIO OUTPUT OCCURRED. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE ALLEGATION AND A ROOT CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9310421 ↗MalfunctionOct 30, 2019Wireless Communication Problem; Wireless Communication Problem
IT WAS REPORTED THAT LOSS OF CONNECTION OCCURRED. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE ALLEGATION AND A ROOT CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9257777 ↗MalfunctionOct 30, 2019Defective Alarm; Defective Alarm
IT WAS REPORTED THAT INTERMITTENT AUDIO OUTPUT OCCURRED. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE ALLEGATION AND A ROOT CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9257775 ↗MalfunctionOct 3, 2019Unable to Obtain Readings; Unable to Obtain Readings
IT WAS REPORTED THAT ERROR ICON DISPLAYED OCCURRED. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9151706 ↗MalfunctionJul 30, 2019Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
IT WAS REPORTED THAT THE RECEIVER INITIALIZING SCREEN WITHOUT MANUAL RESTART OCCURRED. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE ALLEGATION AND A ROOT CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8843335 ↗MalfunctionJul 30, 2019Unexpected Shutdown; Unexpected Shutdown
IT WAS REPORTED THAT A UNEXPECTED RECEIVER SHUT-DOWN OCCURRED. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE ALLEGATION AND A ROOT CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8843331 ↗MalfunctionJul 30, 2019Unable to Obtain Readings; Unable to Obtain Readings
IT WAS REPORTED THAT THE RECEIVER DISPLAYED ERR CALL TECH SUPPORT OCCURRED . NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE ALLEGATION AND A ROOT CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8843330 ↗MalfunctionJul 25, 2019Defective Alarm; Defective Alarm
IT WAS REPORTED THAT INTERMITTENT AUDIO OUTPUT OCCURRED. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE ALLEGATION AND A ROOT CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8829352 ↗MalfunctionJul 20, 2019Unable to Obtain Readings; Unable to Obtain Readings
IT WAS REPORTED THAT ERROR ICON DISPLAYED OCCURRED. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8809975 ↗MalfunctionJul 18, 2019Unable to Obtain Readings; Unable to Obtain Readings
IT WAS REPORTED THAT THE RECEIVER DISPLAYED ERR HWBBT. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE ALLEGATION AND A ROOT CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8805451 ↗MalfunctionJul 16, 2019Wireless Communication Problem; Wireless Communication Problem
IT WAS REPORTED THAT A LOSS OF CONNECTION OCCURRED. NO DATA WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE ALLEGATION AND A ROOT CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8796482 ↗MalfunctionMay 31, 2019Unable to Obtain Readings; Unable to Obtain Readings
IT WAS REPORTED THAT A "ERR 224" ERROR WAS DISPLAYED ON THE RECEIVER. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8660531 ↗MalfunctionMay 22, 2019Unable to Obtain Readings; Unable to Obtain Readings
IT WAS REPORTED THAT THE RECEIVER DISPLAYED ERR. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE ALLEGATION AND A ROOT CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8634707 ↗MalfunctionApr 23, 2019Unable to Obtain Readings; Unable to Obtain Readings
IT WAS REPORTED THAT THE RECEIVER DISPLAYED ERRHWBAT. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE ALLEGATION AND A ROOT CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8541127 ↗MalfunctionApr 18, 2019Unable to Obtain Readings; Unable to Obtain Readings
IT WAS REPORTED THAT THE RECEIVER DISPLAYED ERRHWBBT. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE ALLEGATION AND A ROOT CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8530026 ↗MalfunctionApr 10, 2019Wireless Communication Problem; Wireless Communication Problem
IT WAS REPORTED THAT A LOSS OF CONNECTION OCCURRED. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE ALLEGATION AND A ROOT CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8502265 ↗MalfunctionApr 6, 2019Unable to Obtain Readings; Unable to Obtain Readings
IT WAS REPORTED THAT AN ERROR ICON WAS DISPLAYED ON THE RECEIVER. NO DATA WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE ALLEGATION AND A ROOT CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8489806 ↗MalfunctionMar 29, 2019Unable to Obtain Readings; Unable to Obtain Readings
DEXCOM WAS MADE AWARE ON (B)(4) 2019 THAT ON (B)(6) 2019 THE RECEIVER DISPLAYED ERRHWBAT. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WAS RETURNED FOR EVALUATION. THE COMPLAINT CONFIRMATION OF THE ERROR ICON COULD NOT BE DETERMINED. A ROOT CAUSE COULD NOT BE DETERMINED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8467129 ↗MalfunctionMar 19, 2019Wireless Communication Problem; Wireless Communication Problem
DEXCOM WAS MADE AWARE ON (B)(4) 2019, THAT ON (B)(6) 2019, A LOSS OF CONNECTION OCCURRED. NO ADDITIONAL EVENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. LOSS OF CONNECTION COULD NOT BE DETERMINED. THE ROOT CAUSE COULD NOT BE DETERMINED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8432256 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P120005. One submission often covers many models, so check the product and lot details in each record.
- Z-1561-2020 · Feb 3, 2020 · TerminatedDexcom G5 Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monitoring device indicated for detecting trends and tracki
- Z-1560-2020 · Feb 3, 2020 · TerminatedDexcom G4 PLATINUM Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monitoring device indicated for detecting trends a
Other Sensor, Glucose, Invasive devices
- Dexcom G4 Platinum Sensor 9500-27Dexcom, Inc. · Sensor, Glucose, Invasive2 recalls2 deaths99,426 reports
- Dexcom G5 Transmitter Kit STT-GF-001Dexcom, Inc. · Sensor, Glucose, Invasive1 death58,932 reports
- Dexcom G5 Mobile IOS App SW10611Dexcom, Inc. · Sensor, Glucose, Invasive54,544 reports
- Dexcom G5 Transmitter 9438-06Dexcom, Inc. · Sensor, Glucose, Invasive15,360 reports
- Dexcom G5 Mobile Receiver MT22719Dexcom, Inc. · Sensor, Glucose, Invasive1 death12,594 reports
- Dexcom G4 SBT Transmitter 9438-05Dexcom, Inc. · Sensor, Glucose, Invasive1 death9,041 reports
- Dexcom G5 Mobile Receiver MT22719-BLUDexcom, Inc. · Sensor, Glucose, Invasive7,685 reports
- Dexcom G5 Mobile Receiver Kit STK-GF-001Dexcom, Inc. · Sensor, Glucose, Invasive1 recall6,345 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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