MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-551NAS; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-551NAS

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Hyperglycemia (1905)

Event Date 12/12/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.The customer¿s blood glucose level was 330 mg/dl at the time of the incident and treated with insulin pump.The customer also reported that the insulin pump battery does not last long and died without warning.Customer stated that a new battery cap has already been used and that did not resolve the battery issue.The customer stated that the drive support cap was normal and that the insulin pump was not exposed to high magnetic fields and was able to complete the rewind process.The customer was advised to discontinue use of the insulin pump and to revert to the back-up plan.The insulin pump is being replaced and is expected to return for analysis.

Manufacturer Narrative

Device passed the operating currents measurement, self test, displacement test, rewind, basic occlusion test, occlusion test, prime test and excessive no delivery test.No motor error alarm during testing noted.Motor passed motor test.No unexpected low battery alarm or battery power loss alarm noted.

• Brand Name: 530G INSULIN PUMP MMT-551NAS
• Type of Device: ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• Manufacturer Contact: gerwin de graaff ; ceiba norte ind. park #50 road; juncos 00777--386
• MDR Report Key: 7156023
• MDR Text Key: 96127290
• Report Number: 2032227-2017-78609
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169503663
• UDI-Public: (01)00643169503663
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 07/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-551NAS
• Device Catalogue Number: MMT-551NAS
• Device Lot Number: A4551NASJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2018
• Initial Date Manufacturer Received: 12/14/2017
• Initial Date FDA Received: 12/29/2017
• Supplement Dates Manufacturer Received: 06/25/2018
• Supplement Dates FDA Received: 07/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 58 YR
• Patient Weight: 184