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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MINIMED MMT-508 MINIMED 508 PUMP, INFUSION, INSULIN

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MEDTRONIC MINIMED MMT-508 MINIMED 508 PUMP, INFUSION, INSULIN Back to Search Results
Model Number MMT-508UC
Device Problem No Display / Image
Event Date 01/21/2019
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.

 
Event Description

It was reported that the insulin pump had a blank display. The customer's blood glucose level was unknown. The insulin pump will not be returned for analysis.

 
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Brand NameMMT-508 MINIMED 508
Type of DevicePUMP, INFUSION, INSULIN
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 Key8291796
Report Number2032227-2019-01047
Device Sequence Number1
Product CodeLZG
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 01/31/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/31/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberMMT-508UC
Device Catalogue NumberMMT-508UC
Device LOT Number0000071034
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/21/2019
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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