Dexcom G5 Mobile Receiver MT22719-BLURecalls & reported problems

Summary

The FDA's MAUDE database contains 7,685 adverse event reports that list this exact device (DI 00386270000279), received between Oct 19, 2015 and Feb 6, 2017 — classified as 27 injuries, 7,658 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (5,644 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 7,685 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 6, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  DEXCOM WAS MADE AWARE ON (B)(6) 2017, THAT ON (B)(6) 2017, THE RECEIVER DISPLAYED ERROR 121. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WERE RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6303485 ↗
• MalfunctionFeb 3, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. THE RECEIVER LOG WAS REVIEWED AND SCREEN ERROR ALARMS AND FIRMWARE ERRORS WERE OBSERVED. THE REPORTED EVENT OF AN ERROR ICON DISPLAY WAS CONFIRMED DURING LOG REVIEW. A ROOT CAUSE COULD NOT BE DETERMINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6301880 ↗
• MalfunctionFeb 3, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. THE DATA LOG WAS REVIEWED AND FIRMWARE ERRORS AND SCREEN ERROR ALARMS WERE OBSERVED. THE REPORTED EVENT OF AN ERROR ICON DISPLAY WAS CONFIRMED DURING LOG REVIEW. A ROOT CAUSE COULD NOT BE DETERMINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6301878 ↗
• MalfunctionFeb 3, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  DEXCOM WAS MADE AWARE ON (B)(6) 2017, THAT ON (B)(6) 2017, THE RECEIVER DISPLAYED ERROR HWBAT. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WERE RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6301869 ↗
• MalfunctionFeb 3, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  THE COMPLAINT RECEIVER DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND THE UNIVERSAL SERIAL BUS (USB) CONNECTOR WAS FOUND TO BE DISLODGED. FUNCTIONAL TESTING AND DATA DOWNLOAD WAS UNABLE TO BE PERFORMED BECAUSE THE DEVICE WAS RECEIVED IN A CONDITION MAKING EVALUATION IMPOSSIBLE. THE REPORTED EVENT OF AN ERROR ICON DISPLAY WAS NOT CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6301864 ↗
• MalfunctionJan 30, 2017No Audible Alarm; No Audible Alarm

  THE RECEIVER WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECTS WERE FOUND. A "TRY IT" MANUAL TEST WAS PERFORMED AND SPEAKER DID NOT SOUND. THE REPORTED EVENT OF NO AUDIO OUTPUT WAS CONFIRMED. THE ROOT CAUSE WAS DETERMINED TO BE A DEFECTIVE SPEAKER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6287766 ↗
• MalfunctionJan 30, 2017Defective Alarm; Defective Alarm

  DEXCOM WAS MADE AWARE ON (B)(6) 2017, TO CLAIM INTERMITTENT AUDIO OUTPUT ON (B)(6) 2017. THERE WAS NO REPORT OF ANY INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6287600 ↗
• MalfunctionJan 30, 2017Defective Alarm; Defective Alarm

  DEXCOM WAS MADE AWARE ON (B)(6) 2017, TO CLAIM INTERMITTENT AUDIO OUTPUT ON (B)(6) 2017 . THERE WAS NO REPORT OF ANY INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6287417 ↗
• MalfunctionJan 30, 2017Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  DEXCOM WAS MADE AWARE ON (B)(6) 2017 THAT THE RECEIVER INITIALIZED WITHOUT A MANUAL RESTART ON (B)(6) 2017. THERE WAS NO REPORT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. DATA WAS RECEIVED BUT DOES NOT REFLECT THE PRODUCT AT FAULT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6287405 ↗
• MalfunctionJan 30, 2017Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  DEXCOM WAS MADE AWARE ON (B)(6) 2017 THAT THE RECEIVER INITIALIZED WITHOUT A MANUAL RESTART ON (B)(6) 2017. THERE WAS NO REPORT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6287398 ↗
• MalfunctionJan 30, 2017Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED AND NO PHYSICAL DAMAGE WAS OBSERVED. THE RECEIVER WAS STUCK ON THE INITIALIZING SCREEN, SHUTDOWN AND RE-INITIALIZED CONTINUOUSLY. AN INTERIOR INSPECTION WAS PERFORMED AND THE INSPECTION PASSED. DUE TO THE DEVICE PERPETUALLY REBOOTING, THE REPORTED EVENT OF AN INITIALIZING SCREEN WITHOUT A MANUAL RESTART WAS CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6286320 ↗
• MalfunctionJan 30, 2017Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED AND NO PHYSICAL DAMAGE WAS OBSERVED. THE RECEIVER WAS STUCK ON THE INITIALIZING SCREEN, SHUTDOWN AND RE-INITIALIZED CONTINUOUSLY. AN INTERIOR INSPECTION WAS PERFORMED AND THE INSPECTION PASSED. DUE TO THE DEVICE PERPETUALLY REBOOTING, THE REPORTED EVENT OF AN INITIALIZING SCREEN WITHOUT A MANUAL RESTART WAS CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6286317 ↗
• MalfunctionJan 30, 2017Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED AND NO PHYSICAL DAMAGE WAS OBSERVED. THE RECEIVER WAS STUCK ON THE INITIALIZING SCREEN, SHUTDOWN AND RE-INITIALIZED CONTINUOUSLY. AN INTERIOR INSPECTION WAS PERFORMED AND THE INSPECTION PASSED. DUE TO THE DEVICE PERPETUALLY REBOOTING, THE REPORTED EVENT OF AN INITIALIZING SCREEN WITHOUT A MANUAL RESTART WAS CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6286316 ↗
• MalfunctionJan 30, 2017Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  DEXCOM WAS MADE AWARE ON (B)(6) 2017 THAT THE RECEIVER INITIALIZED WITHOUT A MANUAL RESTART ON (B)(6) 2017. THE CUSTOMER COMPLAINT OF AN INITIALIZING SCREEN WITHOUT MANUAL RESTART COULD NOT BE CONFIRMED. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED AND NO PHYSICAL DAMAGE WAS OBSERVED. THE RECEIVER WAS STUCK ON THE INITIALIZING SCREEN, SHUTDOWN AND RE-INITIALIZED CONTINUOUSLY. AN INTERIOR INSPECTION WAS PERFORMED AND THE INSPECTION PASSED. DUE TO THE DEVICE PERPETUALLY REBOOTING, THE REPORTED EVENT OF AN INITIALIZING SCREEN WITHOUT A MANUAL RESTART WAS CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6286311 ↗
• MalfunctionJan 26, 2017Wireless Communication Problem; Wireless Communication Problem

  DEXCOM WAS MADE AWARE ON (B)(6) 2017 THAT ON (B)(6) 2017, PATIENT EXPERIENCED A LOSS OF CONNECTION BETWEEN THE TRANSMITTER AND RECEIVER. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6280886 ↗
• MalfunctionJan 26, 2017Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  DEXCOM WAS MADE AWARE ON (B)(6) 2017 THAT ON (B)(6) 2017 THE RECEIVER INITIALIZED WITHOUT A MANUAL RESTART. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. DATA WAS PROVIDED FOR EVALUATION. THE REPORT OF THE RECEIVER INITIALIZING WITHOUT MANUAL RESTART COULD NOT BE CONFIRMED VIA DATA. THE ROOT CAUSE COULD NOT BE DETERMINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6279357 ↗
• MalfunctionJan 26, 2017Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  DEXCOM WAS MADE AWARE ON (B)(6) 2017 THAT ON (B)(6) 2017 THE RECEIVER INITIALIZED WITHOUT A MANUAL RESTART. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WERE PROVIDED FOR EVALUATION. THE REPORT OF THE RECEIVER INITIALIZING WITHOUT MANUAL RESTART COULD NOT BE CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6279309 ↗
• MalfunctionJan 26, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  DEXCOM WAS MADE AWARE ON (B)(6) 2016, THAT ON (B)(6) 2016, THE RECEIVER DISPLAYED ERR121. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. THE RECEIVER WAS RETURNED FOR EVALUATION. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. THE RECEIVER DATA LOG WAS DOWNLOADED AND REVIEWED AND FIRMWARE ERRORS WERE OBSERVED. THE REPORTED EVENT OF THE RECEIVER DISPLAYING ERR121 WAS CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6278831 ↗
• MalfunctionJan 26, 2017Wireless Communication Problem; Wireless Communication Problem

  DEXCOM WAS MADE AWARE ON (B)(6) 2017, THAT ON (B)(6) 2017, THE PATIENT HAD A LOSS OF CONNECTION. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. NO PRODUCT WAS PROVIDED FOR EVALUATION. HOWEVER, DATA LOG WAS PROVIDED REVIEWED FOR EVALUATION ON (B)(6) 2017. COMPLAINT FOR A LOSS OF CONNECTION COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED, POST INVESTIGATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6278340 ↗
• MalfunctionJan 25, 2017Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  DEXCOM WAS MADE AWARE ON (B)(6) 2017 THAT ON (B)(6) 2017 THE RECEIVER INITIALIZED WITHOUT A MANUAL RESTART. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WERE PROVIDED FOR EVALUATION. THE REPORT OF THE RECEIVER INITIALIZING WITHOUT MANUAL RESTART COULD NOT BE CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6278096 ↗
• MalfunctionJan 25, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  DEXCOM WAS MADE AWARE ON (B)(6) 2016, THAT ON (B)(6) 2016, THE RECEIVER DISPLAYED ERR121. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. THE RECEIVER HAS BEEN RECEIVED FOR DEVICE INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF DEVICE INVESTIGATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6277813 ↗
• MalfunctionJan 25, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  DEXCOM WAS MADE AWARE ON (B)(4) 2016, THAT ON (B)(6) 2016, THE RECEIVER DISPLAYED ERR121. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WERE RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6277808 ↗
• MalfunctionJan 25, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  THE COMPLAINT RECEIVER DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND "CALL TECH SUPPORT" ERROR WAS OBSERVED ON THE SCREEN. THE DATA LOG COULD NOT BE RETRIEVED AND FUNCTIONAL TESTING COULD NOT BE PERFORMED BECAUSE OF THE "CALL TECH SUPPORT" ERROR. THE CUSTOMER COMPLAINT WAS CONFIRMED BECAUSE HARDWARE ERROR WAS DISPLAYED. THE ROOT CAUSE COULD NOT BE DETERMINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6277804 ↗
• MalfunctionJan 25, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  DEXCOM WAS MADE AWARE ON (B)(6) 2016, THAT ON (B)(6) 2016, THE RECEIVER DISPLAYED ERR121. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WERE RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6277781 ↗
• MalfunctionJan 25, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  DEXCOM WAS MADE AWARE ON (B)(6) 2016, THAT ON (B)(6) 2016, THE RECEIVER DISPLAYED ERR121. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WERE RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6277780 ↗

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 · Terminated
  Dexcom 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 · Terminated
  Dexcom G4 PLATINUM Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monitoring device indicated for detecting trends a