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

Model Number MMT-551LNAB

Device Problem Insufficient Information (3190)

Patient Problems Hyperglycemia (1905); Vomiting (2144); Diabetic Ketoacidosis (2364); Respiratory Tract Infection (2420)

Event Date 12/28/2017

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

Event Description

The customer was reported via phone call that, the customer was hospitalized on (b)(6) 2027 due to diabetes ketoacidosis and sinus infection with high blood glucose of 364 mg/dl.The blood glucose at the time of the incident was 408 mg/dl.The significant events leading to hospitalization that was vomiting.Based on customer report customer does not allege pump was under delivering.The drive support cap appears normal.Assisted with performing the high pressure test which was passed.Customer advised to change entire set, reservoir and insulin and treat per healthcare professional instructions.The insulin pump will not be returned for analysis.

• Brand Name: 530G INSULIN PUMP MMT-551LNAB
• 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: 7184765
• MDR Text Key: 97053116
• Report Number: 3004209178-2018-42894
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169507692
• UDI-Public: (01)00643169507692
• 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
• Report Date: 01/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-551LNAB
• Device Catalogue Number: MMT-551LNAB
• Device Lot Number: A4551LNABJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/31/2017
• 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): Hospitalization
• Patient Age: 54 YR
• Patient Weight: 54