MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-751NAL; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-751NAL

Device Problems Improper or Incorrect Procedure or Method (2017); Device Displays Incorrect Message (2591); Moisture or Humidity Problem (2986)

Patient Problem Hyperglycemia (1905)

Event Date 10/25/2017

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 button error and a high blood glucose event.The customer¿s blood glucose was 522 mg/dl at the time of incident.Customer stated that the insulin pump alarmed button error after battery was changed.Customer also reported that the insulin pump was exposed to moisture that could have led to button error.Button error troubleshooting was performed and unable to confirm if the time is advancing due to button error alarm.Customer also reported to have experienced a high blood glucose of 522 mg/dl and unable to treat due to backup plan was not available.No high blood glucose troubleshooting was performed.The customer was advised to discontinue use of pump and revert to back-up plan.The insulin pump is being replaced and is expected to return for analysis.

Manufacturer Narrative

Pump received with unresponsive buttons due to moisture damage at keypad traces.No button error alarm noted.Traces of corrosion found at the electronic assembly and motor assembly per visual inspection.Unable to perform functional testing including the displacement, operating currents, unexpected alarm error test, rewind, basic occlusion, occlusion, prime and excessive no delivery test due to unresponsive buttons.Pump received with minor scratched lcd window, cracked case at the display window corners, cracked lcd window, cracked belt clip slot, cracked battery tube threads, missing end cap sticker, stained address/serial number label and cracked reservoir tube lip.

• Brand Name: 530G INSULIN PUMP MMT-751NAL
• 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: 6994202
• MDR Text Key: 90798876
• Report Number: 2032227-2017-63295
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169503694
• UDI-Public: (01)00643169503694
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 04/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-751NAL
• Device Catalogue Number: MMT-751NAL
• Device Lot Number: A4751NALJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/30/2018
• 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 Outcome(s): Other
• Patient Age: 44 YR
• Patient Weight: 160