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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723RNAH; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
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MEDTRONIC MINIMED PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723RNAH; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR Back to Search Results
Model Number MMT-723RNAH
Date of Event 10/26/2017
Type of Reportable Event Serious Injury
Additional 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 or Problem Description
The customer reported via phone call that they were hospitalized due to high blood glucose on (b)(6) 2017 with blood glucose of 599 mg/dl.Patient's current blood glucose value: 312 mg/dl.The customer experienced symptoms such as nausea, dry mouth and dehydration.Drive support cap appears normal (slightly indented).The customer was treated with manual injection.The customer was wearing the insulin pump during the hospitalization.The insulin pump is not expected to be returned for analysis.
 
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Brand Name
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723RNAH
Common Device Name
PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
Manufacturer (Section D)
MEDTRONIC MINIMED
18000 devonshire st.
northridge CA 91325 1219
MDR Report Key7000311
Report Number2032227-2017-63741
Device Sequence Number19155734
Product Code OYC
UDI-Device Identifier00613994904416
UDI-Public(01)00613994904416
Combination Product (Y/N)N
Initial Reporter StateWA
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Patient
Type of Report Initial
Report Date (Section B) 11/03/2017
1 Device was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Lay User/Patient
Device Model NumberMMT-723RNAH
Device Catalogue NumberMMT-723RNAH
Device Lot NumberA000204714
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/27/2017
Initial Report FDA Received Date11/03/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
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