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

Model Number MMT-554CMH

Device Problems Crack (1135); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/02/2017

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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.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

Customer called to report damage to the reservoir.Customer reported that there is a crack in the reservoir lip and the reservoir is not staying in place.Customer's blood glucose at the time of the incident was 160 mg/dl.Product is not expected to return.

Manufacturer Narrative

The insulin pump was received with minor scratched lcd window, broken reservoir tube lip, missing reservoir tube o ring,cracked case at the display window corners, cracked lcd window, cracked belt clip slot, missing end cap sticker, stained address label, stained serial number label and cracked battery tube threads.A test reservoir was installed and did not lock in place due to complete broken reservoir tube lip.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-554CMH
• 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: 6811370
• MDR Text Key: 83491773
• Report Number: 2032227-2017-39288
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00643169528703
• UDI-Public: (01)00643169528703
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 12/14/2017

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-554CMH
• Device Catalogue Number: MMT-554CMH
• Device Lot Number: A7554CMHJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/28/2017
• 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