BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 19922113 · Received August 6, 2024

    Report

    Report Number
    3004753838-2024-195241
    Event Type
    Malfunction
    Date Received
    August 6, 2024
    Date of Event
    May 15, 2024
    Report Date
    August 6, 2024
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    K213919
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    SKIP TO NAVIGATION SKIP TO MAIN CONTENT COMPLAINTS HOME TASKS COMPLAINTS MEDICAL REVIEWS MDRS MIRS CANADA VIGILANCE REPORTING OTHER REGULATORY REPORTS INVESTIGATIONS GROUP DASHBOARDS REPORTS COMPLAINT (B)(4). PATH ATTACHMENTS NO ATTACHMENTS AVAILABLE! TABS DETAILS PATIENT/REPORTER INFORMATION AUDIT TRAIL RELATED COMPLAINTS NO OF DAYS FOR DECISION TREE 0 DT COMPLETION DATE 8/1/2024 COMPLAINT NO (B)(4) CLASSIFICATION CODE AS ALLEGED 215 CLASSIFICATION CODE DESCRIPTION SIGNAL LOSS SOURCE PHONE OSVC ID NUMBER (B)(4) OSVC REFERENCE NUMBER (B)(4). OSVC CREATED BY MXJ0923 RECORD CATEGORY COMPLAINT REGION NORTH AMERICA GROUP NORTH AMERICA - 215 PSR PSR OWNER (B)(6) STATUS COMPLAINT REVIEW COMPLETE RECORD TYPE COMPLAINT PENDING MEDICAL REVIEW PENDING MEDICAL REVIEW PENDING DECISION TREES PENDING DECISION TREES PENDING DEV INVESTIGATION PENDING DEV INVESTIGATION PENDING HAR PENDING HAR PENDING UPDATE REQUEST / TASK PENDING UPDATE REQUEST / TASK UPDATE REQUEST STATUS NO UPDATE REQUEST COUNTRY OF PURCHASE UNITED STATES COUNTRY OF INCIDENT UNITED STATES CITY OF INCIDENT NA REPORTER ORGANIZATION NA DISTRIBUTOR UNIQUE COMPLAINT NO (DUCN) NA DISTRIBUTOR COMPLAINT DATE FILES ADDED TO COMPLAINT PATIENT BIRTHDATE (B)(6) 2014 PATIENT WEIGHT AGE AT THE TIME OF EVENT 9 PATIENT GENDER FEMALE REPORTER TYPE PARENT PEDIATRIC OR ADULT PEDIATRIC AGE UNIT YEARS SERIOUS ADVERSE EVENT INFORMATION (0) EVENT DESCRIPTION SIGNAL LOSS CONCLUSION ADVISED PT THAT THE ORDER REPLACEMENT STILL UNDER REVIEW AND WAITING FOR APPROVAL, EDUCATE PT THAT HE WILL BE GETTING A CONFIRMATION ONCE THE ORDER APPROVED. ADVISED PT THAT THE DELIVERY STILL WITHIN THE TIME FRAME. PLEASE DISREGARD ALL TSQS NOT RELATED TO THIS CODE. CONFIRMED EMAIL ADDRESS AND SHIPPING ADDRESS. WEIGHT: 78 LBS NEED ASSISTANCE FOR THIS NEWLY CREATED ACCOUNT - (B)(6) PRODUCT (SKU) AND QTY TO BE SENT: RELATED SR: 240711-008933 SHIPPING METHOD: FEDEX GROUND SHIPPING ADDRESS: (B)(6) WAS THE RED FLAG ACCOUNT PROCESS CHECKED? Y IS THE ISSUE SHOWING IN INQUISITOR? N IS THERE AN UNUSUAL ACCOUNT BEHAVIOR ALERT DATE 7/11/2024 EVENT DATE AS ALLEGED 5/15/2024 INSERTION DATE AS ALLEGED NI WAS IFU FOLLOWED? NA PATIENT TOOK APAP/ACETAMINOPHEN? NA NO OF DAYS SINCE OPENED 25 DOWNLOAD IDENTIFIER UNABLE / UNWILLING TO ANSWER DOWNLOAD IDENTIFIER TYPE ACCOUNT NAME AUTOMATED DATA ANALYSIS REQUEST IS PATIENT USING A RECEIVER,MOBILE,BOTH? MOBILE DEVICE IS THE DATE EXACT OR APPROXIMATE? APPROXIMATE INSERTION SITE ARM DEATH REPORTED DEATH REPORTED DATE OF DEATH MEDICAL INTERVENTION/SERIOUS INJURY MEDICAL INTERVENTION/SERIOUS INJURY RGA CREATED? NO,THE PRODUCT ISN'T ABLE TO BE RETURNED RGA REFERENCE NUMBER NA NO RGA JUSTIFICATION PRODUCT UNAVAILABLE RGA FOLLOW UP COMPLETED? INVALID EMAIL ADDRESS TROUBLESHOOTING QUESTIONS (6+) NAVIGATION MODE PQ NO QUESTION ANSWER PQ-039666315 WAS THE DEVICE MORE THAN 20 FEET OR 6-METER AWAY FROM THE TRANSMITTER FOR MORE THAN 15MIN? NO PQ-039666316 HOW LONG DID THE SIGNAL LOSS OCCUR? 3+HR PQ-039666317 IS THE PATIENT USING ANY OTHER BLUETOOTH ACCESSORIES AT THE TIME OF SIGNAL LOSS? NO PQ-039666318 WHAT TIME DID THE SIGNAL LOSS OCCUR? NI PQ-039666319 WHAT DEVICE(S) ARE DISPLAYING THE SIGNAL LOSS? PHONE PQ-039666320 WHAT DEVICE(S) IS/ARE THE USER'S TRANSMITTER PAIRED WITH? PHONE VIEW ALL TROUBLE SHOOTING QUESTIONS PRODUCT LINE AS ALLEGED STP-AT-012 PRODUCT LINE DESCRIPTION AS ALLEGED G7 US RETAIL SENSOR/TRANSMITTER 1-PACK RECEIVER SERIAL NUMBER AS ALLEGED NA PRODUCT GENERATION AS ALLEGED G7 LOT NUMBER AS ALLEGED NI NCMR DETAILS AS ALLEGED MANUFACTURING DATE AS ALLEGED EXPIRATION DATE AS ALLEGED TRANSMITTER SERIAL NUMBER AS ALLEGED NI CATEGORY AS ALLEGED WEARABLE PRODUCT LINE AS INVESTIGATED STP-AT-012 PRODUCT LINE DESCRIPTION AS INVESTIGATED G7 US RETAIL SENSOR/TRANSMITTER 1-PACK RECEIVER SERIAL NUMBER AS INVESTIGATED NA PRODUCT GENERATION AS INVESTIGATED G7 LOT NUMBER AS INVESTIGATED NI NCMR DETAILS AS INVESTIGATED MANUFACTURING DATE AS INVESTIGATED EXPIRATION DATE AS INVESTIGATED TRANSMITTER SERIAL NUMBER AS INVESTIGATE NI CATEGORY AS INVESTIGATED WEARABLE PRODUCT REGISTRATION STP-AT-012 PRODUCT SYSTEM AS INVESTIGATED MODEL NUMBER ADDITIONAL PRODUCT INFORMATION (0) DATA ANALYSIS SUMMARY NO PRODUCT OR DATA RELATED TO ISSUE WAS PROVIDED. EVENT DATE AS INVESTIGATED 5/15/2024 ALLEGATION CONFIRMED BY DATA UNDETERMINED DATA ANALYSIS STATUS NO DOWNLOAD IDENTIFIER PROVIDED PLATFORM DATA SOURCE NA DATA AVAILABLE? NO MANUFACTURER'S NARRATIVE (B5) IT WAS REPORTED THAT A SIGNAL LOSS 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1805614 DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Female