BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR MMT-7020D1 GUARDIAN SN3 1PK OUS1

    MDR report key: 9929361 · Received April 6, 2020

    Report

    Report Number
    2032227-2020-102180
    Event Type
    Injury
    Date Received
    April 6, 2020
    Date of Event
    March 26, 2020
    Report Date
    April 6, 2020
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    GLUCOSE MONITORING IS ESSENTIAL FOR ALL PEOPLE WITH DIABETES, ESPECIALLY WHEN INSULIN TREATED. TO MANAGE THEIR THERAPY AND TO AVOID HYPOGLYCEMIA OR HYPERGLYCEMIA, PATIENTS GENERALLY PERFORM SELF-MONITORING OF BLOOD GLUCOSE (SMBG) MEASUREMENTS. INSTEAD, CONTINUOUS GLUCOSE MONITORING (CGM) SYSTEMS HAVE BECOME AN OPTION FOR MANY PATIENTS. THE MEAN ABSOLUTE RELATIVE DIFFERENCE (MARD) IS A PARAMETER OFTEN USED TO DESCRIBE CGM SYSTEM ACCURACY. HOWEVER, AS MARD IS DEPENDENT ON THE EXACT TEST SETTING AND AS THERE ARE NO MANDATORY SPECIFICATIONS FOR TESTING PROCEDURES, MARD VALUES GIVEN IN THE LITERATURE FOR DIFFERENT SYSTEMS MAY NOT BE DIRECTLY COMPARABLE. THE BEST WAY TO COMPARE DIFFERENT CGM SYSTEMS IS THEREFORE TO PERFORM A STUDY IN WHICH THE SYSTEMS ARE WORN IN PARALLEL IN THE SAME SUBJECT. THIS WAS AN OPEN, PROSPECTIVE STUDY PERFORMED ACCORDING TO GOOD CLINICAL PRACTICE AND THE DECLARATION OF HELSINKI (ICH-GCP) AT TWO INVESTIGATIONAL SITES, ONE IN AUSTRIA (PRIVATKLINIK WEHRLE-DIAKONISSEN, SALZBURG) AND ONE IN GERMANY (INSTITUT FÜR DIABETES-TECHNOLOGIE, FORSCHUNGSUND ENTWICKLUNGSGESELLSCHAFT MBH AN DER UNIVERSITÄT ULM). THE PRIMARY OBJECTIVE WAS TO DETERMINE THE MARD OF THREE CGM SYSTEMS. SECONDARY OBJECTIVES WERE THE EVALUATION OF FURTHER PERFORMANCE MEASURES AND USABILITY ASPECTS OF THE SYSTEMS. THREE CE-MARKED CGM SYSTEMS WERE USED IN THIS STUDY: <NAME OMITTED>, GUARDIAN¿ CONNECT SYSTEM (MEDTRONIC MINIMED INC, NORTHRIDGE, CA, USA) (GC), AND <NAME OMITTED>. THE INTENDED WEARING TIME WAS 7 DAYS FOR <NAME OMITTED> AND <NAME OMITTED>, AND 6 DAYS FOR GC. THRESHOLDS FOR WARNINGS ABOUT LOW AND HIGH GLUCOSE LEVELS WERE SET TO 70 MG/DL AND 280 MG/DL, RESPECTIVELY, IN ALL DEVICES. DEVICE DATA WERE DOWNLOADED USING THE RESPECTIVE ASSOCIATED SOFTWARE. THE <NAME OMITTED> WAS USED TO CALIBRATE THE CGM SYSTEMS AND FOR CAPILLARY COMPARISON MEASUREMENTS. INSULIN TREATED PEOPLE WITH TYPE 1 OR TYPE 2 DIABETES MELLITUS WHO WERE DIAGNOSED AT LEAST 12 MONTHS PRIOR TO THE STUDY AND WITHOUT FURTHER RISK FACTORS FOR CARDIOVASCULAR DISEASES WERE ELIGIBLE TO PARTICIPATE. ALL PARTICIPANTS FOLLOWED THEIR CURRENT THERAPY DURING THE STUDY, EXCEPT FOR DYNAMIC PHASES WHERE INSULIN DOSES WERE DETERMINED BY A STUDY PHYSICIAN. ALL TREATMENT DECISIONS WERE BASED ON SMBG VALUES. THE STUDY WAS PERFORMED IN A MIXED INPATIENT AND OUTPATIENT SETTING FOR 7 DAYS (DISTRIBUTED OVER 8 STUDY DAYS) PER PARTICIPANT. ON STUDY DAY 1, A SENSOR OF EACH CGM SYSTEM WAS APPLIED ON THE ABDOMEN OF THE PARTICIPANTS IN RANDOMIZED POSITIONS AFTER DISINFECTION OF THE APPLICATION SITES. THE STUDY PERIOD INCLUDED 4 HOME USE DAYS REPRESENTING THE PARTICIPANTS¿ DAILY ROUTINE AND 2 DAYS WITH STUDY SITE VISITS. DAYS WITH STUDY SITE VISITS WERE RANDOMIZED AMONG THE PARTICIPANTS. ON HOME USE DAYS, PARTICIPANTS WERE INSTRUCTED TO PERFORM SMBG MEASUREMENTS BEFORE AND 2 HOURS AFTER EACH MEAL, BEFORE INSULIN ADMINISTRATION, BEFORE BEDTIME, AND FOR CGM CALIBRATION. ALL SENSORS WERE REMOVED AFTER THEIR REGULAR WEARING PERIOD, THAT IS, ON STUDY DAY 7 FOR GC AND ON STUDY DAY 8 FOR <NAME OMITTED> AND <NAME OMITTED>. INSERTION SITES AND PATCH ADHESION WERE EVALUATED ON A DAILY BASIS. IF A LOW OR HIGH GLUCOSE WARNING OCCURRED, IT WAS RECORDED AND AN SMBG MEASUREMENT WAS TO BE PERFORMED FOR CONFIRMATION. ALL SYSTEM FAILURES AND ADVERSE EVENTS WERE DOCUMENTED. THE EVALUATION OF DETECTION RATES FOR LOW AND HIGH GLUCOSE VALUES WAS BASED ON THRESHOLDS OF 70 MG/DL AND 280 MG/DL, RESPECTIVELY. A LOW GLUCOSE VALUE WAS CONSIDERED DETECTED IF AT LEAST ONE CGM VALUE WAS BELOW OR EQUAL TO THE LOW THRESHOLD WITHIN ± 15 MINUTES OF THE SMBG VALUE. CORRESPONDINGLY, HIGH GLUCOSE DETECTION AND WARNING RATES WERE CALCULATED BASED ON GLUCOSE VALUES ABOVE OR EQUAL TO THE HIGH THRESHOLD. A TOTAL OF 71 PARTICIPANTS WERE SCREENED AT THE TWO STUDY SITES (17 DID NOT MEET THE ELIGIBILITY CRITERIA). ALL 54 PARTICIPANTS THAT STARTED THE EXPERIMENTAL PHASE COMPLETED THE STUDY. THE PARTICIPANTS WERE 45 ± 13 (MEAN ± STANDARD DEVIATION) YEARS OF AGE, 52% FEMALE, WITH A BMI AT SCREENING OF 26.2 ± 3.8 KG/M2. THE MAJORITY OF PARTICIPANTS GAVE POSITIVE RATINGS FOR ALL THREE SYSTEMS. FOR GC, PATCH REACTIONS LIKE ITCHING OR REDNESS WERE REPORTED MORE FREQUENTLY THAN FOR THE OTHER SYSTEMS. IN TOTAL, 8 PARTICIPANTS REPORTED PROBLEMS WITH <NAME OMITTED>, 20 PARTICIPANTS WITH GC, AND 25 PARTICIPANTS WITH <NAME OMITTED>, MOST OF WHICH WERE CONNECTION PROBLEMS BETWEEN TRANSMITTER AND RECEIVER. DURING THE STUDY, 111 ADVERSE EVENTS WERE REPORTED BY 50 PARTICIPANTS. NONE OF THE ADVERSE EVENTS WERE CLASSIFIED AS SERIOUS. EIGHTY-FOUR ADVERSE EVENTS WERE CONSIDERED RELATED TO THE INVESTIGATIONAL DEVICES (<NAME OMITTED> 17, GC 42, <NAME OMITTED> 25). THE THREE CGM SYSTEMS TESTED IN THIS STUDY SHOWED SIMILAR OVERALL PERFORMANCE WITH DIFFERENCES DEPENDING ON THE SPECIFIC GLUCOSE RANGE, STUDY PHASE (I.E., HOME USE OR STUDY SITE VISITS WITH DYNAMIC PHASES), AND SAMPLE MATERIAL USED FOR COMPARISON. GENERALLY, ALL SYSTEMS WERE RATED POSITIVELY BY MOST USERS, BUT WITH DIFFERENCES IN INDIVIDUAL PREFERENCES BASED ON USABILITY ASPECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393919 SENSOR MMT-7020D1 GUARDIAN SN3 1PK OUS1 ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC MINIMED MMT-7020D1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other