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 Mechanical Problem (1384); Device Difficult to Program or Calibrate (1496); Obstruction of Flow (2423); No Apparent Adverse Event (3189)

Patient Problems Hyperglycemia (1905); Anxiety (2328)

Event Date 01/25/2019

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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.

Event Description

The customer reported via phone call that they experienced high blood glucose level and buttons was not responding.Customer¿s blood glucose level was 400 mg/dl and 500 mg/dl.The customer did not provide details on symptoms related to the high blood glucose level episodes.Customer also reported that the insulin pump rewind taking longer than normal and unexplained no delivery alerts.Customer stated that to press harder to work.Customer stated that the hospitalization was not due to insulin delivery and insulin pump not worn within 48 hrs of going to hospitalization.The device will not be returned for analysis.

• 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 ; 8185464805
• MDR Report Key: 8747716
• MDR Text Key: 149619452
• Report Number: 2032227-2019-23270
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00763000161170
• UDI-Public: (01)00763000161170
• 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
• Report Date: 07/01/2019

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-751LNAS
• Device Catalogue Number: MMT-751LNAS
• Device Lot Number: A6751LNASJ
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/24/2019
• Initial Date FDA Received: 07/01/2019
• Date Device Manufactured: 09/26/2018
• 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
• Treatment: FRN-UNK-RSVR, UNOMED INF SET
• Patient Outcome(s): Other
• Patient Age: 77 YR
• Patient Weight: 128