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

Model Number MMT-751LNAS

Device Problems Fluid/Blood Leak (1250); High Test Results (2457)

Patient Problem Diabetic Ketoacidosis (2364)

Event Date 01/10/2018

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 that they had high blood glucose.The customer's blood glucose was 430 mg/dl.This morning, their blood glucose was 380 mg/dl.Their current blood glucose was 254 mg/dl, the customer treated high blood glucose with a syringe and insulin pump.The customer was neither hospitalized nor admitted for high blood glucose.The drive support cap was normal.Based on customer report, customer does not allege pump was under delivering.It was also reported that the insulin pump was exposed to fluid in the past with no moisture was visible in the pump.The insulin pump passed the self test.The customer's mother called back to report that insulin was leaking into the insulin pump.The customer's blood glucose were still high.The customer's mother stated the customer may be going into diabetic ketoacidosis.The insulin pump will be returned for analysis.

Manufacturer Narrative

Insulin pump passed displacement test, self test, rewind test, basic occlusion test, prime or compromised force sensor system alarm test, excessive no delivery test and occlusion test.Insulin pump received with cracked reservoir tube lip and minor scratches on display window noted.Drive support cap was inspected and no anomaly was noted.No moisture damage on electronics and motor assembly noted.

• Brand Name: 530G INSULIN PUMP MMT-751LNAS
• 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: 7206619
• MDR Text Key: 97777322
• Report Number: 3004209178-2018-44676
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169507784
• UDI-Public: (01)00643169507784
• 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: 05/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-751LNAS
• Device Catalogue Number: MMT-751LNAS
• Device Lot Number: A4751LNASJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/10/2018
• 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: 29 YR
• Patient Weight: 109