MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-554LWWS; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number MMT-554LWWS

Device Problems Device Displays Incorrect Message (2591); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/26/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.

Event Description

It was reported via phone call the insulin pump alarmed a motor position encoder error.The customer¿s blood glucose level was 136 mg/dl at the time of the incident.The customer was advised to discontinue use of the insulin pump a replacement will be sent.The insulin pump will be returned for analysis.

Manufacturer Narrative

Pump alarmed motor error during rewind due to motor encoder signal out of phase.Unable to perform the self-test, unexpected alarm error test, displacement test, rewind, basic occlusion test, occlusion test, prime test and excessive no delivery test or verify operating currents and motor position encoder error alarm due to motor error alarms.Pump received with minor scratched lcd window, cracked case at the reservoir tube window corners, cracked belt clip slot, cracked battery tube threads, stained address/serial number label and cracked reservoir tube lip.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.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-554LWWS
• Type of Device: PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• Manufacturer Contact: gerwin de graaff ; ceiba norte ind. park #50 road; juncos 00777--386
• MDR Report Key: 6811747
• MDR Text Key: 83485629
• Report Number: 2032227-2017-39341
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00643169515697
• UDI-Public: (01)00643169515697
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-554LWWS
• Device Catalogue Number: MMT-554LWWS
• Device Lot Number: A2554LWWSJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1