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

Model Number MMT-723NAB

Device Problems Break (1069); Device Displays Incorrect Message (2591); Power Problem (3010)

Patient Problem Injury (2348)

Event Date 01/27/2017

Event Type  Injury  

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

Customer reported via phone call that they experienced motor error alarm, hospitalization, exposure to high magnetic field, button error, off no power and damaged battery cap.Customer's blood glucose value was unknown.Customer stated that he was hospitalized due to carbon dioxide poisoning.The customer stated that the pump alarmed motor error during ct scan.The insulin pump will be returned for analysis.

Manufacturer Narrative

All buttons functioned properly.No button error alarm occurred during testing, no damage on the keypad assembly, and no unlocked lcd keypad connector during visual inspection noted.The pump was received with the operating currents within specification and passed the self-test, unexpected restart, rewind, basic occlusion, occlusion, prime, excessive no delivery and displacement tests.The rewind functioned properly and no motor error alarms, unexpected excessive no delivery alarms, or displacement anomalies were noted.The pump was monitored and no unexpected off no power alarms occurred during testing.The motor was tested outside the device and it passed.The pump was received with a stripped battery cap coin slot, a cracked reservoir tube lip, cracked battery tube threads, a cracked case at the display window corner, minor scratches on the lcd window, and a scratched reservoir tube window.

• Brand Name: PARADIGM REAL-TIME REVEL 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: 6343734
• MDR Text Key: 67812504
• Report Number: 3004209178-2017-91666
• 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: 02/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-723NAB
• Device Catalogue Number: MMT-723NAB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/28/2017
• 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 Outcome(s): Hospitalization
• Patient Age: 70 YR
• Patient Weight: 127