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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
Device Problem Scratched Material (3020)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/08/2018
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 issues with esc button having to press more than once to work, rejecting new batteries, no alert when battery was low and scratch in casing.Blood glucose value was unknown at the time of the incident.Customer did not troubleshoot.The product will not be returned for analysis.
 
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Brand Name
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723RNAH
Type of Device
PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
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 Key7661614
MDR Text Key113194907
Report Number2032227-2018-07832
Device Sequence Number1
Product Code OYC
UDI-Device Identifier00643169221475
UDI-Public(01)00643169221475
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 Other
Type of Report Initial
Report Date 07/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberMMT-723RNAH
Device Catalogue NumberMMT-723RNAH
Device Lot NumberA000290384
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/08/2018
Initial Date FDA Received07/03/2018
Date Device Manufactured02/27/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age47 YR
Patient Weight142
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