MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP; INSULIN INFUSION PUMP / SENSOR AUGMENTED

Model Number MMT-751NAP

Device Problems Device Displays Incorrect Message (2591); Positioning Problem (3009)

Patient Problem Hyperglycemia (1905)

Event Date 04/05/2017

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 222 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 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 insulin pump passed the rewind, basic occlusion, prime and displacement test.Pump was received with stuck motor error alarm loop during bolus delivery.The motor was tested outside of the device and passed.The motor may have had and intermittent failure that was not detected during our testing.We were unable to verify alarm in the alarm history due to history file overwritten.No check settings alarm and no off no power alarm noted.The insulin pump was received with cracked case at the display window corner, cracked reservoir tube lip, minor scratched lcd window and cracked battery tube threads.

• Brand Name: 530G INSULIN 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: 6496309
• MDR Text Key: 73102890
• Report Number: 3004209178-2017-44177
• Device Sequence Number: 1
• Product Code: OYC
• Combination Product (y/n): N
• PMA/PMN Number: 120010
• 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: 05/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-751NAP
• Device Catalogue Number: MMT-751NAP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/24/2017
• 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: 28 YR
• Patient Weight: 52