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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP; INSULIN INFUSION PUMP / SENSOR AUGMENTED

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MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP; INSULIN INFUSION PUMP / SENSOR AUGMENTED Back to Search Results
Model Number MMT-523NAP
Device Problems Device Displays Incorrect Message (2591); Electromagnetic Compatibility Problem (2927)
Patient Problem Hyperglycemia (1905)
Event Date 07/14/2013
Event Type  malfunction  
Manufacturer Narrative
The insulin pump passed displacement test, rewind, and basic occlusion test.The insulin pump was received with stuck motor error alarm loop during bolus delivery and motor position encoder error alarm confirm in alarm history screen.The motor was tested outside the device and passed.The motor may have had an intermittent failure not detected during our testing.No motion sensor test failure alarm noted during testing.This is a remediation mdr.Medtronic diabetes implemented revised mdr reportability criteria effective on july 1, 2014.Subsequently, medtronic diabetes conducted a one year retrospective review of complaints.This event was retrospectively identified to be reportable based on the revised mdr reportability criteria.This mdr related to the (b)(4) manufacturing site has been assigned a medwatch number from the medtronic minimed (b)(4).
 
Event Description
The customer reported via phone call that they received a motor error alarm and a motor position encoder error alarm.The customer reported that they also received a motion sensor test failure alarm.The customer's blood glucose was 158 mg/dl at the time of incident.The customer stated that the drive support cap appeared normal.The customer stated that the insulin pump was exposed to airport scanners.The customer was advised that the insulin pump will need to be replaced.The customer was advised to disconnect from the insulin pump and revert to back-up plan.The insulin pump will be returned for analysis.
 
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Brand Name
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
Type of Device
INSULIN INFUSION PUMP / SENSOR AUGMENTED
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
ceiba norte ind. park #50
road 31 km 24.4
juncos PR 00777 3869
Manufacturer (Section G)
MEDTRONIC MINIMED
18000 devonshire street
northridge CA 91325 1219
Manufacturer Contact
gerwin de graaff
18000 devonshire street
northridge, CA 91325-1219
8185764805
MDR Report Key5991299
MDR Text Key56478975
Report Number2032227-2016-22691
Device Sequence Number1
Product Code OYC
Combination Product (y/n)N
PMA/PMN Number
P980022
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Patient
Type of Report Initial
Report Date 07/14/2013
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-523NAP
Device Catalogue NumberMMT-523NAP
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/18/2013
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 07/14/2013
Initial Date FDA Received09/30/2016
Was Device Evaluated by Manufacturer? Yes
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 Age37 YR
Patient Weight75
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