Dexcom Replacement Receiver Kit STR-SD-001Recalls & reported problems
Dexcom, Inc. · Replacement Receiver Kit · Class 3
Quick summary
This Dexcom replacement receiver kit is the handheld unit that displays continuous glucose sensor readings. The 33 reports describe receiver problems such as alarms failing or sounding intermittently, screens freezing or showing error icons, the device shutting down or restarting on its own, and wireless connections dropping so readings do not come through. No deaths or injuries were reported. 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
- 33
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 30386270000324), received between Jun 16, 2017 and Oct 10, 2024 — classified as 33 malfunctions.
The most frequently reported specific device problem is “Defective Alarm” (10 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Defective Alarm10
- Wireless Communication Problem5
- Display or Visual Feedback Problem4
- Inappropriate or Unexpected Reset4
- Device Operates Differently Than Expected3
- No Audible Alarm3
- Unable to Obtain Readings3
- Unexpected Shutdown1
Patient problems
- No Consequences Or Impact To Patient25
- No Clinical Signs, Symptoms or Conditions8
Recent adverse event reports
The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 10, 2024Unexpected Shutdown; Unexpected Shutdown
IT WAS REPORTED THAT AN UNEXPECTED RECEIVER SHUTDOWN OCCURRED. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20424558 ↗MalfunctionNov 10, 2023Defective Alarm; Defective Alarm
IT WAS REPORTED THAT INTERMITTENT AUDIO OUTPUT OCCURRED. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18116729 ↗MalfunctionOct 19, 2023Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
IT WAS REPORTED THAT THE RECEIVER INITIALIZED WITHOUT A MANUAL RESTART OCCURRED. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17968822 ↗MalfunctionAug 29, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THAT THE RECEIVER DISPLAY WAS FROZEN. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17644318 ↗MalfunctionJun 13, 2023Unable to Obtain Readings; Unable to Obtain Readings
IT WAS REPORTED THAT ERROR ICON DISPLAYED OCCURRED. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17119460 ↗MalfunctionMar 29, 2023No Audible Alarm; No Audible Alarm
IT WAS REPORTED THAT NO AUDIO OUTPUT OCCURRED. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16639333 ↗MalfunctionMar 10, 2023Unable to Obtain Readings; Unable to Obtain Readings
IT WAS REPORTED THAT ERROR ICON DISPLAYED OCCURRED. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16522090 ↗MalfunctionJan 10, 2023Unable to Obtain Readings; Unable to Obtain Readings
IT WAS REPORTED THAT ERROR ICON DISPLAYED OCCURRED. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16130465 ↗MalfunctionJan 29, 2018Wireless Communication Problem; Wireless Communication Problem
DEXCOM WAS MADE AWARE ON (B)(4) 2017 THAT ON (B)(6) 2017, A LOSS OF CONNECTION BETWEEN THE TRANSMITTER AND RECEIVER OCCURRED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. DATA WAS PROVIDED FOR INVESTIGATION. CONFIRMATION OF THE COMPLAINT WAS CONFIRMED VIA DATA. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7225377 ↗MalfunctionJan 26, 2018Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
DEXCOM WAS MADE AWARE ON (B)(4) 2018 THAT ON (B)(6) 2018 THE RECEIVER INITIALIZED WITHOUT A MANUAL RESTART. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WERE PROVIDED FOR EVALUATION. THE CONFIRMATION OF THE COMPLAINT IS UNDETERMINED. A ROOT CAUSE COULD NOT BE DETERMINED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7223207 ↗MalfunctionJan 24, 2018Wireless Communication Problem; Wireless Communication Problem
DEXCOM WAS MADE AWARE ON (B)(4) 2017 THAT ON (B)(6) 2017, A LOSS OF CONNECTION BETWEEN THE TRANSMITTER AND RECEIVER OCCURRED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. DATA WAS RETURNED AND EVALUATED. THE REPORTED EVENT OF A LOSS OF CONNECTION WAS CONFIRMED VIA DATA. A PROBABLE CAUSE COULD NOT BE DETERMINED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7215892 ↗MalfunctionJan 24, 2018No Audible Alarm; No Audible Alarm
THE RECEIVER WAS RETURNED FOR EVALUATION. AN EXTERIOR VISUAL INSPECTION WAS PERFORMED AND PASSED. THE RECEIVER WAS CHARGED AND WILL BOOT. THE RECEIVER LOG WAS DOWNLOADED AND REVIEWED, FINDING NO ERRORS RELATED TO THE COMPLAINT. A GLOBAL RECEIVER FUNCTIONAL TEST WAS PERFORMED, AND IT PASSED THE SPEAKER TESTS. A GLOBAL COMMUNICATION TOOL SOFTWARE TEST WAS PERFORMED, AND IT PASSED SOUND TESTS. MANUAL "TRY IT" TESTING AND WAS PERFORMED AND PASSED. THE REPORTED EVENT OF NO AUDIO OUTPUT WAS NOT CONFIRMED. A PROBABLE CAUSE COULD NOT BE DETERMINED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7215475 ↗MalfunctionJan 22, 2018Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
DEXCOM WAS MADE AWARE ON (B)(4) 2018 THAT ON (B)(6) 2018 THE RECEIVER INITIALIZED WITHOUT A MANUAL RESTART. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WERE PROVIDED FOR EVALUATION. THE CONFIRMATION OF THE COMPLAINT IS UNDETERMINED. A ROOT CAUSE COULD NOT BE DETERMINED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7211121 ↗MalfunctionJan 22, 2018Defective Alarm; Defective Alarm
DEXCOM WAS MADE AWARE ON (B)(4) 2017 THAT ON (B)(6) 2017, 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 7209618 ↗MalfunctionJan 18, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected
DEXCOM WAS MADE AWARE ON (B)(4) 2017 THAT ON (B)(6) 2017 THE RECEIVER DISPLAYED AN ERROR MESSAGE OF NOT RECEIVING GLUCOSE READINGS. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WERE PROVIDED FOR EVALUATION. THE CONFIRMATION OF THE COMPLAINT IS UNDETERMINED. A ROOT CAUSE COULD NOT BE DETERMINED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7203939 ↗MalfunctionJan 13, 2018Wireless Communication Problem; Wireless Communication Problem
DEXCOM WAS MADE AWARE ON (B)(4) 2017 THAT ON (B)(6) 2017, A LOSS OF CONNECTION BETWEEN THE TRANSMITTER AND RECEIVER OCCURRED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7188687 ↗MalfunctionJan 12, 2018Wireless Communication Problem; Wireless Communication Problem
DEXCOM WAS MADE AWARE ON (B)(4) 2017 THAT ON (B)(6) 2017, PATIENT EXPERIENCED A LOSS OF CONNECTION BETWEEN THE TRANSMITTER, SMART DEVICE, AND RECEIVER. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WERE PROVIDED FOR EVALUATION. THE COMPLAINT CONFIRMATION OF A LOSS OF CONNECTION COULD NOT BE DETERMINED. A ROOT CAUSE COULD NOT BE DETERMINED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7185961 ↗MalfunctionJan 11, 2018No 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 NO AUDIO OUTPUT COULD NOT BE DETERMINED. A ROOT CAUSE COULD NOT BE DETERMINED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7184583 ↗MalfunctionJan 10, 2018Defective Alarm; Defective Alarm
DEXCOM WAS MADE AWARE ON (B)(4) 2017 THAT ON (B)(6) 2017 THE RECEIVER HAD INTERMITTENT AUDIO OUTPUT. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. NO PRODUCT WAS PROVIDED FOR EVALUATION. THE COMPLAINT CONFIRMATION OF INTERMITTENT AUDIO OUTPUT COULD NOT BE DETERMINED. A ROOT CAUSE COULD NOT BE DETERMINED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7181038 ↗MalfunctionJan 10, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected
DEXCOM WAS MADE AWARE ON (B)(4) 2017, THAT ON (B)(6) 2017, THE PATIENT STATED THE ARROWS ON THE SCREEN OF THE RECEIVER WERE GOING IN THE WRONG DIRECTION WHEN THE VALUES WERE DISPLAYED. NO MEDICAL INTERVENTION WAS REPORTED. ADDITIONAL EVENT OR PATIENT INFORMATION IS NOT AVAILABLE. NO DATA OR PRODUCT WAS PROVIDED FOR EVALUATION. THE COMPLAINT CONFIRMATION WAS UNABLE TO BE DETERMINED. A ROOT CAUSE WAS NOT DETERMINED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7179875 ↗MalfunctionJan 5, 2018Defective Alarm; Defective Alarm
THE RECEIVER WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. RECEIVER CHARGE AND BOOT TEST WAS PERFORMED AND PASSED. A REVIEW OF THE DOWNLOADED DATA LOG DID NOT FIND ANY ERRORS RELATED TO THE CUSTOMER COMPLAINT. FUNCTIONAL TESTING WAS PERFORMED THERE WAS NO FAILURE DETECTED. G5 GLOBAL COMMUNICATION TOOL TONE AT MEDIUM TEST WAS PERFORMED AND PASS SOUND TESTS. A "TRY IT" MANUAL DROP TEST WAS PERFORMED AND THE TEST PASSED. THE REPORTED EVENT OF AN INTERMITTENT AUDIO OUTPUT WAS NOT CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED AS THE REPORTED ALLEGATION WAS NOT FOUND.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7170196 ↗MalfunctionJan 3, 2018Defective Alarm; Defective Alarm
THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. FUNCTIONAL TESTING WAS PERFORMED AND THE AND THERE WAS NO FAILURE DETECTED. A MANUAL TEST WAS PERFORMED AND THERE WAS VIBRATION OMITTING FROM THE DEVICE. A REVIEW OF THE DOWNLOADED DATA LOG DID NOT FIND ANY ERRORS RELATED TO THE CUSTOMER COMPLAINT. THE REPORTED EVENT OF AN INTERMITTENT VIBRATION WAS NOT CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7161188 ↗MalfunctionJan 3, 2018Defective Alarm; Defective Alarm
DEXCOM WAS MADE AWARE ON (B)(4) 2017 THAT ON (B)(6) 2017 THE RECEIVER HAD INTERMITTENT AUDIO OUTPUT. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. NO PRODUCT WAS PROVIDED FOR EVALUATION. THE COMPLAINT CONFIRMATION OF INTERMITTENT AUDIO OUTPUT COULD NOT BE DETERMINED. A ROOT CAUSE COULD NOT BE DETERMINED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7160909 ↗MalfunctionDec 28, 2017Defective Alarm; Defective Alarm
DEXCOM WAS MADE AWARE ON (B)(4) 2017 THAT ON (B)(6) 2017 THE RECEIVER HAD INTERMITTENT AUDIO OUTPUT. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. THE RECEIVER HAS BEEN RECEIVED FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7151640 ↗MalfunctionDec 15, 2017Defective Alarm; Defective Alarm
DEXCOM WAS MADE AWARE ON (B)(4) 2017 THAT ON (B)(6) 2017 THE RECEIVER HAD INTERMITTENT VIBRATION. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. NO PRODUCT WAS PROVIDED FOR EVALUATION. THE COMPLAINT CONFIRMATION OF INTERMITTENT VIBRATION COULD NOT BE DETERMINED. A ROOT CAUSE COULD NOT BE DETERMINED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7123877 ↗
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, Non-Adjunctive devices
- Dexcom G5 Mobile Transmitter Kit (Medicare) STT-MC-001Dexcom, Inc. · Sensor, Glucose, Invasive, Non-Adjunctive18,422 reports
- Dexcom Receiver MT22949Dexcom, Inc. · Sensor, Glucose, Invasive, Non-Adjunctive7,702 reports
- Dexcom G5 Mobile Replacement Receiver Kit (Medicare) STR-MC-001Dexcom, Inc. · Sensor, Glucose, Invasive, Non-Adjunctive4,734 reports
- Dexcom G5 Mobile Android App SW10940Dexcom, Inc. · Sensor, Glucose, Invasive, Non-Adjunctive3,843 reports
- Dexcom Receiver Kit (Medicare) STK-MD-001Dexcom, Inc. · Sensor, Glucose, Invasive, Non-Adjunctive963 reports
- Dexcom G5 Mobile Receiver Kit (Medicare) STK-MC-001Dexcom, Inc. · Sensor, Glucose, Invasive, Non-Adjunctive1 recall494 reports
- Dexcom Receiver Kit STK-SD-001Dexcom, Inc. · Sensor, Glucose, Invasive, Non-Adjunctive145 reports
- Dexcom Replacement Receiver Kit (Medicare) STR-MD-001Dexcom, Inc. · Sensor, Glucose, Invasive, Non-Adjunctive27 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.