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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM REAL-TIME INSULIN INFUSION PUMP; INSULIN INFUSION PUMP / SENSOR AUGMENTED

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MEDTRONIC MINIMED PARADIGM REAL-TIME INSULIN INFUSION PUMP; INSULIN INFUSION PUMP / SENSOR AUGMENTED Back to Search Results
Model Number MMT-522LWWS
Device Problems Device Displays Incorrect Message (2591); Electromagnetic Compatibility Problem (2927)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/13/2014
Event Type  malfunction  
Manufacturer Narrative
The insulin pump was received with motor error alarm during rewind due to motor encoder signal out of phase.The pump was unable to perform displacement test due to motor error alarm.The pump had cracked battery tube threads.
 
Event Description
It was reported of a motor error from the insulin pump.The customer's blood glucose reading was unknown.The customer stated that the pump was exposed to high magnetic field.The customer will be sent a replacement pump.
 
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Brand Name
PARADIGM REAL-TIME INSULIN INFUSION PUMP
Type of Device
INSULIN INFUSION PUMP / SENSOR AUGMENTED
Manufacturer (Section D)
MEDTRONIC MINIMED
18000 devonshire street
northridge CA 91325
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 Key5987592
MDR Text Key56197370
Report Number2032227-2016-22575
Device Sequence Number1
Product Code OYC
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P980022
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial
Report Date 06/13/2014
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-522LWWS
Device Catalogue NumberMMT-522LWWS
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/08/2014
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/13/2014
Initial Date FDA Received09/29/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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