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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-723RNAL; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
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MEDTRONIC MINIMED PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723RNAL; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR Back to Search Results
Model Number MMT-723RNAL
Medical Device Problem Codes Adverse Event Without Identified Device or Use Problem (2993); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code Hyperglycemia (1905)
Date of Event 10/12/2012
Type of Reportable Event Serious Injury
Event or Problem Description
The customer reported via phone call that insulin pump had high blood glucose.The blood glucose at the time of the incident was 186 mg/dl, current blood glucose was 600 mg/dl.The customer was assisted with troubleshooting.The device will not be returned for analysis.
 
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Brand Name
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723RNAL
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 Key8368865
Report Number2032227-2019-01713
Device Sequence Number1960239
Product Code OYC
UDI-Device Identifier00613994904409
UDI-Public(01)00613994904409
Combination Product (Y/N)N
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 02/25/2019
1 Device was Involved in the Event
1 Patient 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-723RNAL
Device Catalogue NumberMMT-723RNAL
Device Lot NumberA000205306
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/30/2018
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/18/2019
Initial Report FDA Received Date02/25/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
FRN-UNK-RSVR,UNOMED INF
Outcome Attributed to Adverse Event Other;
Patient Age66 YR
Patient Weight78
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