MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722WWS; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number MMT-722WWS

Device Problems Mechanical Problem (1384); Insufficient Flow or Under Infusion (2182)

Patient Problems Hyperglycemia (1905); Dizziness (2194); Urinary Frequency (2275); Polydipsia (2604)

Event Date 08/17/2019

Event Type  Injury  

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.

Event Description

It was reported that they experienced high blood glucose level.The customer¿s blood glucose levels were 20 mmol/l, 24 mmol/l, 27 mmol/l, 21 mmol/l, 17.1 mmol/l and 18 mmol/l.The customer had been using insulin pump system within 48 hours of reported high blood glucose event.The customer reported that they treated high blood glucose level with the bolus.The customer reported that they experienced groggy, frequent urination and thirst as a symptom of high blood glucose level.Customer was neither in emergency room, nor admitted into hospital, nor was emergency medical services dispatched as a result of high blood glucose.The customer alleged the insulin pump for under delivery because they continue to bolus but the blood glucose level remained high.They reported that the drive support cap appeared normal.The customer stated that they ran a self test which was interrupted by low battery alert and the insulin pump passed the second self test.They also reported that the insulin pump had a motor error and they were able to clear it and rewind the insulin pump.The customer stated that the insulin pump also passed the displacement test.The customer declined troubleshooting for high blood glucose level.The insulin pump will not be returned for analysis.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722WWS
• 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 ; 8185464805
• MDR Report Key: 8934013
• MDR Text Key: 155630871
• Report Number: 2032227-2019-53368
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00613994401977
• UDI-Public: (01)00613994401977
• Combination Product (y/n): N
• Reporter Country Code: SF
• 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
• Report Date: 08/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-722WWS
• Device Catalogue Number: MMT-722WWS
• Device Lot Number: B2722WWSJ
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/19/2019
• Date Device Manufactured: 05/06/2016
• 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
• Treatment: FRN-UNK-RSVR, UNOMED INF SET
• Patient Outcome(s): Other