Dexcom G4 Platinum (Pedicatric) Receiver KitRecalls & reported problems across all models

We found 3 models of Dexcom G4 Platinum (Pedicatric) Receiver Kit by Dexcom, Inc. in the FDA's device registry (GUDID). Together they are named in 39 adverse event reports in the FDA's MAUDE database, received between Aug 18, 2016 and Jun 19, 2019 — classified as 39 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (17 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 (Pedicatric) Receiver Kit problems

Dexcom G4 Platinum (Pedicatric) Receiver Kit models

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

• Dexcom G4 Platinum (Pedicatric) Receiver Kit STK-KD-BLU

  Sensor, Glucose, Invasive
  15 reports
• Dexcom G4 Platinum (Pedicatric) Receiver Kit STK-KD-001

  Sensor, Glucose, Invasive
  12 reports
• Dexcom G4 Platinum (Pedicatric) Receiver Kit STK-KD-PNK

  Sensor, Glucose, Invasive
  12 reports

Recent Dexcom G4 Platinum (Pedicatric) Receiver Kit adverse event reports

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

• MalfunctionJun 19, 2019Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT THE RECEIVER CEASED TO FUNCTION. 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 8713740 ↗
• MalfunctionMar 14, 2019Unexpected Shutdown; Unexpected Shutdown

  DEXCOM WAS MADE AWARE ON (B)(4) 2019 THAT ON (B)(6) 2019 THE RECEIVER CEASED TO FUNCTION. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. THE CONFIRMATION OF THE COMPLAINT IS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8423214 ↗
• MalfunctionOct 24, 2018Unable to Obtain Readings; Unable to Obtain Readings

  DEXCOM WAS MADE AWARE ON (B)(4) 2018 THAT ON (B)(6) 2018 THE RECEIVER DISPLAYED "ERR HWBBT". NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. THE COMPLAINT CONFIRMATION OF THE ERROR ICON COULD NOT BE DETERMINED. A PROBABLE CAUSE COULD NOT BE DETERMINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8000914 ↗
• MalfunctionOct 17, 2018Defective Alarm; Defective Alarm

  DEXCOM WAS MADE AWARE ON (B)(4) 2018 THAT ON (B)(6) 2018, THE RECEIVER HAD INTERMITTENT AUDIO OUTPUT. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. NO PRODUCT WAS PROVIDED FOR EVALUATION. THE COMPLAINT CONFIRMATION OF THE RECEIVER HAVING INTERMITTENT AUDIO OUTPUT COULD NOT BE DETERMINED. A PROBABLE CAUSE COULD NOT BE DETERMINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7974821 ↗
• MalfunctionOct 17, 2018Defective Alarm; Defective Alarm

  DEXCOM WAS MADE AWARE ON (B)(4) 2018 THAT ON (B)(6) 2018, THE RECEIVER HAD INTERMITTENT VIBRATION. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. NO PRODUCT WAS PROVIDED FOR EVALUATION. THE COMPLAINT CONFIRMATION OF THE RECEIVER HAVING INTERMITTENT VIBRATION COULD NOT BE DETERMINED. A PROBABLE CAUSE COULD NOT BE DETERMINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7974819 ↗
• MalfunctionApr 25, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  DEXCOM WAS MADE AWARE ON (B)(4) 2018, THAT ON (B)(6) 2018, AN ERRHWRS WAS DISPLAYED ON THE RECEIVER. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WAS AVAILABLE FOR EVALUATION. CONFIRMATION OF THE ERROR ICON AND A PROBABLE CAUSE COULD NOT BE DETERMINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7457761 ↗
• MalfunctionMar 30, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  DEXCOM WAS MADE AWARE ON (B)(4) 2018 THAT ON (B)(6) 2018 THE RECEIVER DISPLAYED "ERR HWBAT". NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. THE COMPLAINT CONFIRMATION OF THE ERROR ICON COULD NOT BE DETERMINED. A PROBABLE CAUSE COULD NOT BE DETERMINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7385422 ↗
• MalfunctionFeb 27, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  DEXCOM WAS MADE AWARE ON (B)(4) 2018, THAT ON (B)(6) 2018, THE RECEIVER DISPLAYED ERR CALL TECH SUPPORT: ERROR. 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 7301725 ↗
• MalfunctionFeb 22, 2018Use of Device Problem; Device Displays Incorrect Message; Use of Device Problem; Device Displays Incorrect Message

  DEXCOM WAS MADE AWARE ON (B)(4) 2018, THAT ON (B)(6) 2018, AN ERROR ICON WAS DISPLAYED ON THE RECEIVER. REPORTEDLY, THE ADULT PATIENT IS USING A PEDIATRIC RECEIVER. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WAS NOT AVAILABLE FOR EVALUATION. CONFIRMATION OF THE ERROR ICON AND A PROBABLE CAUSE COULD NOT BE DETERMINED. LABELING INDICATES: THE DEXCOM SYSTEM IS A GLUCOSE MONITORING DEVICE INDICATED FOR DETECTING TRENDS AND TRACKING PATTERNS IN PERSONS AGES 2 TO 17 YEARS WITH DIABETES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7290668 ↗
• MalfunctionJan 12, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  DEXCOM WAS MADE AWARE ON (B)(4) 2017, THAT ON (B)(6) 2017, THE RECEIVER DISPLAYED ERR HWRF. 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 7185927 ↗
• MalfunctionNov 29, 2017No Audible Alarm; No Audible Alarm

  DEXCOM WAS MADE AWARE ON (B)(4) 2017 THAT ON (B)(6) 2017 THE RECEIVER HAD NO AUDIO OUTPUT. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. NO PRODUCT WAS PROVIDED FOR EVALUATION. THE COMPLAINT CONFIRMATION OF THE RECEIVER HAVING NO AUDIO OUTPUT COULD NOT BE DETERMINED. A ROOT CAUSE COULD NOT BE DETERMINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7067567 ↗
• MalfunctionOct 17, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  DEXCOM WAS MADE AWARE ON (B)(4) 2017, THAT ON (B)(6) 2017, THE RECEIVER DISPLAYED A "CALL TECH SUPPORT HW" ERROR. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WAS 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 6955105 ↗
• MalfunctionOct 16, 2017No Audible Alarm; Use of Device Problem; No Audible Alarm; Use of Device Problem

  DEXCOM WAS MADE AWARE ON (B)(4) 2017 THAT ON (B)(6) 2017 THE RECEIVER HAD NO AUDIO OUTPUT. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WERE PROVIDED FOR EVALUATION. THE REPORTED NO AUDIO OUTPUT COULD NOT BE CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED. REPORTEDLY, AN ADULT PATIENT WAS USING A PEDIATRIC RECEIVER. LABELING INDICATES: THE DEXCOM G4 PLATINUM (PEDIATRIC) CONTINUOUS GLUCOSE MONITORING SYSTEM IS A GLUCOSE MONITORING DEVICE INDICATED FOR DETECTING TRENDS AND TRACKING PATTERNS IN PERSONS AGES 2 TO 17 YEARS WITH DIABETES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6952334 ↗
• MalfunctionSep 8, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DEXCOM WAS MADE AWARE ON (B)(4) 2017, THAT ON (B)(6) 2017, A BUFFER OVERFLOW ERROR ON THE RECEIVER OCCURRED. NO MEDICAL INTERVENTION WAS REPORTED. ADDITIONAL EVENT OR PATIENT INFORMATION IS NOT AVAILABLE. NO PRODUCT OR DATA WERE PROVIDED FOR EVALUATION. THE REPORTED EVENT COULD NOT BE CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6852606 ↗
• MalfunctionSep 1, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  DEXCOM WAS MADE AWARE ON (B)(4) 2017, THAT ON (B)(6) 2017, THE RECEIVER DISPLAYED AN ERR46. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. NO PRODUCT WAS 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 6838071 ↗

Other Dexcom, Inc. products

• Dexcom G613 models · 637,302 reports · 7 recalls
• Dexcom G6 Transmitter2 models · 469,968 reports
• Dexcom G732 models · 325,909 reports · 8 recalls
• Dexcom G521 models · 206,314 reports · 1 recall
• Dexcom G7 GSS (161)4 models · 141,244 reports · 1 recall
• Dexcom G4 Platinum41 models · 119,308 reports · 2 recalls
• Dexcom G7 Receiver4 models · 33,732 reports · 1 recall
• Dexcom G7 GSS (160)4 models · 33,558 reports