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U.S. Department of Health and Human Services

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

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MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED Back to Search Results
Model Number MMT-554CMP
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/13/2015
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. The device will be returned for analysis and further information will follow once the analysis has been completed. No conclusion can be drawn at this time. The insulin pump involved in this event is the paradigm real-time veo insulin infusion pump, which is not marketed in the united states. However, the device is similar to the paradigm real-time insulin infusion pump, which is marketed in the united states.
 
Manufacturer Narrative
The insulin pump received with intermittent button response and button error alarm due to corroded keypad traces. The insulin pump was received with cracked case at the display window corner, cracked reservoir tube lip, minor scratched lcd window, cracked battery tube threads and missing end cap sticker.
 
Event Description
The customer reported via phone call indicating that the insulin pump had keypad anomaly. Customer's blood glucose was 7. 3 mg/dl. The customer stated that the esc buttons are not working. The customer stated that the device was not dropped nor bumped.
 
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Brand NamePARADIGM REAL-TIME INSULIN INFUSION PUMP
Type of DeviceINSULIN 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 PUERTO RICO OPERATIONS CO.
ceiba norte ind. park #50
road 31 km 24.4
juncos PR 00777 3869
Manufacturer Contact
christopher tupper
18000 devonshire street
northridge, CA 91325-1219
8185764313
MDR Report Key4946263
MDR Text Key13712146
Report Number3004209178-2015-78176
Device Sequence Number1
Product Code OYC
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
P980022
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative,company representative
Reporter Occupation Patient
Type of Report Initial,Followup
Report Date 07/13/2015
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/28/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMMT-554CMP
Device Catalogue NumberMMT-554CMP
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/01/2015
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/13/2015
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 Unkown

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