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

Model Number MMT-723NAS

Device Problems Retraction Problem (1536); Device Displays Incorrect Message (2591); Electromagnetic Compatibility Problem (2927)

Patient Problem Hypoglycemia (1912)

Event Date 04/01/2017

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.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's spouse reported via phone call that they experienced low blood glucose of 50 mg/dl.The customer's spouse stated that the emergency medical services came for the low blood glucose.The customer's blood glucose was over 500 mg/dl at the time of call.The customer's spouse stated that they gave correction for low blood glucose with food and glucose.The customer's spouse also reported that they received a motor error alarm.The customer's spouse's blood glucose was unknown at the time of incident.Troubleshooting was done.The customer's spouse stated that the insulin pump was exposed to high magnetic fields.The customer's spouse stated that they were unable to rewind the insulin pump.The customer's spouse was advised that the insulin pump will need to be replaced.The customer was advised to disconnect from the insulin pump and revert to back-up plan.The insulin pump will be returned for analysis.

Manufacturer Narrative

The insulin failed displacement test followed by a motor error alarm during rewind due to motor encoder signal out of phase.Unable to perform functional testing including unexpected restart error test, basic occlusion test, occlusion test, prime test, excessive no delivery test and displacement test due to motor error alarms.The insulin pump was received with operating currents within specifications and passed self-test.The insulin pump had cracked case at the display window corners, minor scratched display window, minor scratched case and minor scratched keypad overlay.

• 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: 6478994
• MDR Text Key: 72336370
• Report Number: 3004209178-2017-41429
• 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: other
• Type of Report: Initial,Followup
• Report Date: 04/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-723NAS
• Device Catalogue Number: MMT-723NAS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2017
• Date Manufacturer Received: 04/14/2017
• 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): Required Intervention
• Patient Age: 57 YR
• Patient Weight: 73