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

Model Number MMT-551NAL

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

Patient Problem Hyperglycemia (1905)

Event Date 04/05/2017

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 reported via phone call the insulin pump alarmed motor error and a motor position encoder error.The customer's blood glucose level was over 500 mg/dl a couple of days ago.The customer was unsure if drive support cap was loose, sticking out or flushed.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 displacement test.The device alarmed prime during the basic occlusion test due to loose/protruded drive support disk.Unable to perform the error test, prime test, excessive no delivery test and occlusion test or test for motor error alarm due to prime alarm.The insulin pump was received with normal operating current.Pump passed self- test and off no power test.The motor was tested outside of the device and passed.The insulin pump was received with minor scratched lcd window, cracked battery tube threads and cracked reservoir tube lip.

• 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: 6496297
• MDR Text Key: 72887831
• Report Number: 3004209178-2017-44178
• 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: 06/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-551NAL
• Device Catalogue Number: MMT-551NAL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/05/2017
• Initial Date FDA Received: 04/15/2017
• Supplement Dates Manufacturer Received: 06/13/2017
• Supplement Dates FDA Received: 07/12/2017
• 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): Other
• Patient Age: 31 YR
• Patient Weight: 100