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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MINIMED PUMP MMT-1715K 630G 3ML PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

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MEDTRONIC MINIMED PUMP MMT-1715K 630G 3ML PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR Back to Search Results
Model Number MMT-XXX
Device Problem Inaccurate Delivery (2339)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/09/2018
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. The device will be returned for analysis and further information will follow once the analysis has been completed. No conclusion can be drawn at this time.

 
Event Description

The customer reported via social media that their insulin pump was delivering imprecise insulin doses. The customer¿s blood glucose level was unknown at the time of the incident. The customer also mentioned imprecise continuous glucose monitoring calibrations. Troubleshooting was not completed as the customer could not be reached. The customer also stated the country of manufacture was not listed on the pump. The insulin pump was returned for analysis per the post.

 
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Brand NamePUMP MMT-1715K 630G 3ML
Type of DevicePUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
Manufacturer (Section D)
MEDTRONIC MINIMED
18000 devonshire st.
northridge CA 91325 1219
Manufacturer (Section G)
MEDTRONIC MINIMED
18000 devonshire st.
northridge CA 91325 1219
Manufacturer Contact
gerwin de graaff
18000 devonshire st.
northridge, CA 91325-1219
MDR Report Key7574928
MDR Text Key110380416
Report Number2032227-2018-04555
Device Sequence Number1
Product Code OZO
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Type of Report Initial
Report Date 06/06/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/06/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberMMT-XXX
Device Catalogue NumberMMT-XXX
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/09/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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