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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-508RUC
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/21/2019
Event Type  Injury  
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

The customer reported that the customer experienced high blood glucose level. The customer¿s blood glucose value was 470 mg/dl. The customer treated their high blood glucose levels with insulin pump and manual injection. 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 Key9127562
Report Number2032227-2019-69804
Device Sequence Number1
Product CodeLZG
Report Source Manufacturer
Source Type CONSUMER
Type of Report Initial
Report Date 09/27/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/27/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberMMT-508RUC
Device Catalogue NumberMMT-508RUC
Device LOT NumberA1508RUC
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/21/2019
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

Patient TREATMENT DATA
Date Received: 09/27/2019 Patient Sequence Number: 1
Treatment
FRN UNK RSR, UNOMED INF SET
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