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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM TRANSLATOR UNIVERSAL

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MEDTRONIC MINIMED PARADIGM TRANSLATOR UNIVERSAL Back to Search Results
Model Number MMT-7018NAU
Device Problem Insufficient Information (3190)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/23/2017
Event Type  malfunction  
Manufacturer Narrative
Unit charge properly and no led anomalies were noted. However, unit failed to communicate during testing, problem isolated to electronic assembly.
 
Event Description
The customer reported via phone call that the uploader was not charging. Customer had tried using different usb, outlets and was not carrying a full charge at all so getting the uploader replaced. The device will be returned for analysis.
 
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Brand NamePARADIGM TRANSLATOR UNIVERSAL
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
8185464805
MDR Report Key8385654
MDR Text Key137969259
Report Number2032227-2019-01886
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 03/04/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/04/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/18/2017
Device Model NumberMMT-7018NAU
Device Catalogue NumberMMT-7018NAU
Device Lot Number840114
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/22/2017
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/22/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/21/2016
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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