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Model Number MMT-UNK
Device Problems Bent (1059); Incorrect Or Inadequate Test Results (2456)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/18/2014
Event Type  malfunction  
Manufacturer Narrative
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. Note: this is a remediation mdr. Medtronic diabetes implemented revised mdr reportability criteria effective on (b)(6) 2014. Subsequently, medtronic diabetes conducted a one year retrospective review of complaints. This event was retrospectively identified to be reportable based on the revised mdr reportability criteria.
Event Description
The customer reported via phone call that they experienced inaccurate readings. The customer's blood glucose was 120 mg/dl and sensor glucose was 78 mg/dl at the time of incident when it triggered threshold suspend. The customer stated that they did have a bent cannula on the sensor. The customer she sweats and the sensor wiggles out of her skin. The sensor will be returned for analysis.
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Brand NameSENSOR
Type of DeviceCGM
Manufacturer (Section D)
18000 devonshire street
northridge CA 91325
Manufacturer (Section G)
18000 devonshire street
northridge CA 91325 1219
Manufacturer Contact
gerwin de graaff
18000 devonshire street
northridge, CA 91325-1219
MDR Report Key5944045
MDR Text Key54815940
Report Number2032227-2016-19560
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 consumer
Reporter Occupation Patient
Type of Report Initial
Report Date 03/18/2014
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/12/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMMT-UNK
Device Catalogue NumberMMT-UNK
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/18/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown