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

Model Number MMT-523LNAL

Device Problem Positioning Problem (3009)

Patient Problem Hyperglycemia (1905)

Event Date 04/20/2017

Event Type  malfunction  

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.The device will be returned for analysis and 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 the insulin pump alarmed motor error and a motor position encoder error.The customer's blood glucose level was 370 mg/dl at the time of the incident.The customer stated that the drive support cap was normal.The customer stated that the insulin pump was not exposed to high magnetic fields.The customer declined to troubleshoot for high readings.The customer was advised to discontinue use of the insulin pump and to revert to the back-up plan.The insulin pump will be returned for analysis.

Manufacturer Narrative

The device had constant motor error alarm during rewind due to motor encoder signal out of phase.Unable to perform self-test, unexpected error test, displacement test, basic occlusion test, occlusion test, prime test, operating currents, off no power test and excessive no delivery test due to motor error alarm.Unable to confirm alarms due to motor error alarm.No cosmetic damage was noted.

• 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: 6516241
• MDR Text Key: 73728976
• Report Number: 3004209178-2017-47191
• 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: 06/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-523LNAL
• Device Catalogue Number: MMT-523LNAL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/01/2017
• 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: 11 YR
• Patient Weight: 32