Dexcom G4 Platinum Replacement Receiver KitRecalls & reported problems across all models

We found 3 models of Dexcom G4 Platinum Replacement Receiver Kit by Dexcom, Inc. in the FDA's device registry (GUDID). Together they are named in 206 adverse event reports in the FDA's MAUDE database, received between Jan 27, 2017 and Aug 21, 2020 — classified as 3 injuries, 203 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (100 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Dexcom G4 Platinum Replacement Receiver Kit problems

Dexcom G4 Platinum Replacement Receiver Kit models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Dexcom G4 Platinum Replacement Receiver Kit STR-GL-001

  Sensor, Glucose, Invasive
  126 reports
• Dexcom G4 Platinum Replacement Receiver Kit STR-GL-BLU

  Sensor, Glucose, Invasive
  54 reports
• Dexcom G4 Platinum Replacement Receiver Kit STR-GL-PNK

  Sensor, Glucose, Invasive
  26 reports

Recent Dexcom G4 Platinum Replacement Receiver Kit adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 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 10439775 ↗
• MalfunctionJan 3, 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 9545514 ↗
• MalfunctionJan 2, 2020Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT SIGNAL LOSS OVER ONE HOUR 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 9538038 ↗
• MalfunctionNov 8, 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 9296248 ↗
• MalfunctionOct 15, 2019Defective Alarm; Defective Alarm

  THE PRODUCT WAS EVALUATED. AN EXTERIOR VISUAL INSPECTION WAS PERFORMED AND PASSED. CHARGED AND BOOT WERE PERFORMED AND PASSED. RECEIVER FUNCTIONAL TESTING WAS PERFORMED AND PASSED. "TRY IT" TESTING WAS PERFORMED AND PASSED. DROP TEST FOR INTERMITTENT AUDIO WAS PERFORMED AND PASSED. CASE OPENED FOR INTERIOR INSPECTION WAS PERFORMED AND PASSED. AUDIO SPEAKER RESISTANCE WAS MEASURED AND PASSED. THE RECEIVER LOG WAS DOWNLOADED AND REVIEWED FINDING NO ERRORS RELATED TO THE COMPLAINT. THE ALLEGATION WAS NOT CONFIRMED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9193667 ↗
• MalfunctionOct 10, 2019Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT SIGNAL LOSS OVER ONE HOUR 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 9177516 ↗
• MalfunctionAug 6, 2019Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT ERROR ICON DISPLAYED OCCURRED. THE PRODUCT WAS EVALUATED. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. A RECEIVER CHARGE TEST WAS PERFORMED AND PASSED. A RECEIVER BOOT TEST WAS PERFORMED AND FAILED DUE TO IT WOULD NOT BOOT. FUNCTIONAL TESTS WERE PERFORMED AND PASSED. THE LOG WAS DOWNLOADED AND REVIEWED FINDING ERROR RELATED TO THE COMPLAINT. THE ALLEGATION WAS CONFIRMED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8864655 ↗
• MalfunctionJul 30, 2019Unexpected 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 8842370 ↗
• MalfunctionJun 21, 2019Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT AN ERRPR CALL TECH SUPPORT ERROR ICON WAS DISPLAYED. 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 8723330 ↗
• MalfunctionJun 6, 2019Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT A "HWBB1" ERROR AND A "CALL TECH SUPPORT" 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 8674154 ↗
• MalfunctionMay 29, 2019Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT A "CALL TECH SUPPORT" 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 8650003 ↗
• MalfunctionMay 21, 2019Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT A LOSS OF CONNECTION OCCURRED. NO DATA WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE ISSUE WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8627302 ↗
• MalfunctionMay 20, 2019Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT A LOSS OF CONNECTION OCCURRED. NO DATA WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE ISSUE WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8626222 ↗
• MalfunctionMay 16, 2019Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT AN "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 8615850 ↗
• MalfunctionApr 26, 2019Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT A "HWRF" 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 8554723 ↗

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