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

Model Number MMT-554LWWL

Device Problems Kinked (1339); High Test Results (2457)

Patient Problem Hyperglycemia (1905)

Event Date 06/21/2018

Event Type  Injury  

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.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

It was reported by the customer's parent that the customer got hospitalized due to high blood glucose on (b)(6) 2018 with blood glucose of 700 mg/dl at the time of the incident.The customer was given intravenous insulin to treat.The customer was wearing the insulin pump during the incident.Troubleshooting was not completed but a self test was carried out before the call without any result.The customer was also hospitalized on (b)(6) 2018 for general adjustment of their blood glucose levels.This was due to fluctuating blood glucose levels mainly at night.The caller stated that the customer eats uncontrollably at night.The customer had a kinked infusion set the day before the incident.The insulin pump will not be returned for analysis.

Manufacturer Narrative

Unit received with all operating currents within spec and passed functional testing including the rewind, basic occlusion test, occlusion test, prime test, excessive no delivery test, self test, error test and displacement test.Pump passed the dat test at 0.08700 inches.No excessive no delivery alarms noted.All bolus delivered during testing were properly recorded at the daily totals and bolus history screens files.A complete analysis and testing of the insulin pump showed that it was functioning properly and passed all functional testing.After testing it was concluded that the device operated within specifications.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-554LWWL
• 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: 7644644
• MDR Text Key: 112721016
• Report Number: 3004209178-2018-85922
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00643169515673
• UDI-Public: (01)00643169515673
• 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: 08/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-554LWWL
• Device Catalogue Number: MMT-554LWWL
• Device Lot Number: A2554LWWLJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2017
• 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