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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MINIMED SENSOR MMT-7040C1 GUARDIAN4 5PK OUS 1 SENSOR, GLUCOSE, INVASIVE

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MEDTRONIC MINIMED SENSOR MMT-7040C1 GUARDIAN4 5PK OUS 1 SENSOR, GLUCOSE, INVASIVE Back to Search Results
Model Number MMT-7040C1
Device Problems Incorrect, Inadequate or Imprecise Resultor Readings (1535); Unexpected Therapeutic Results (1631); Physical Resistance/Sticking (4012)
Patient Problem Hyperglycemia (1905)
Event Date 01/23/2022
Event Type  malfunction  
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Brand NameSENSOR MMT-7040C1 GUARDIAN4 5PK OUS 1
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
MEDTRONIC MINIMED
18000 devonshire st.
northridge CA 91325
Manufacturer (Section G)
MEDTRONIC MINIMED
18000 devonshire st.
northridge CA 91325
Manufacturer Contact
tricha miles
18000 devonshire st.
northridge, CA 91325
7635140379
MDR Report Key13420847
Report Number2032227-2022-108001
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeNL
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 02/01/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/02/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMMT-7040C1
Device Catalogue NumberMMT-7040C1
Was Device Available for Evaluation? No
Date Manufacturer Received01/23/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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