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

Model Number MMT-722NAS

Device Problems Device Displays Incorrect Message (2591); Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/30/2016

Event Type  malfunction  

Manufacturer Narrative

Currently it is unknown whether or not the device may have caused or contributed to the event.The device has been returned, but not yet evaluated.Further information will follow once the analysis has been completed.No conclusion can be drawn at this time.

Event Description

The customer reported via phone call of issues with their insulin pump.The customer states the pump alarmed for radio frequency pic failed self-test.The customer states they had issues with their drive support cap being dislodged and having been walked through pushing it back into place.The customer's blood glucose level at the time of incident was unknown.The customer was advised the pump would be replaced and returned for analysis.

Manufacturer Narrative

The pump was received with a loose/protruded drive support disk, a severely scratched display window and a broken off reservoir tube lip.The pump alarmed compromised force sensor system during the basic occlusion test due to a loose/protruded drive support disk.The pump passed the idle current, run current, self test, off no power, unexpected restart, displacement and rewind tests.Unable to perform the occlusion, prime or excessive no delivery tests due to the compromised force sensor system alarm.No rf pic failed alarm was noted.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP
• Type of Device: INSULIN 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: gerwin de graaff ; 18000 devonshire street; northridge, CA 91325-1219 ; 8185764805
• MDR Report Key: 6277053
• MDR Text Key: 66014188
• Report Number: 3004209178-2017-86339
• Device Sequence Number: 1
• Product Code: OYC
• Combination Product (y/n): N
• PMA/PMN Number: P980022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 02/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-722NAS
• Device Catalogue Number: MMT-722NAS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/31/2016
• Initial Date FDA Received: 01/25/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/04/2017
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 109