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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MINIMED SENSOR CGM

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MEDTRONIC MINIMED SENSOR CGM Back to Search Results
Model Number MMT-7020A
Device Problem Component Missing (2306)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/24/2017
Event Type  malfunction  
Manufacturer Narrative
The reliability analysis inspected 1 opened and used partial guardian sensor and when they performed a visual inspection they found the sensor cannula was retracted inside the sensor base. They did not find a broken cannula during analysis. Unable to confirm customer received sensor in said condition due to customer returned opened and used product. Unable to confirm the insertion and needle complaint because the customer returned the sensor only, they did not return the insertion needle.
 
Event Description
The caller reported via phone call that when they removed the sensor, the sensor electrode was missing. The customer's blood glucose level during the incident was unknown. They were unsure if the cannula was still in the skin. They were referred to their health care professional for instructions. The product was returned for analysis.
 
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Brand NameSENSOR
Type of DeviceCGM
Manufacturer (Section D)
MEDTRONIC MINIMED
18000 devonshire street
northridge CA 91325
Manufacturer (Section G)
MEDTRONIC MINIMED
18000 devonshire street
northridge CA 91325 1219
Manufacturer Contact
gerwin de graaff
18000 devonshire street
northridge, CA 91325-1219
8185764805
MDR Report Key6591793
MDR Text Key76040348
Report Number2032227-2017-99162
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial
Report Date 04/26/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/25/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMMT-7020A
Device Catalogue NumberMMT-7020A
Device Lot NumberC237
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/23/2017
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/26/2017
Was Device Evaluated by Manufacturer? Yes
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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