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

Model Number MMT-551LNAS

Device Problems Invalid Sensing (2293); Incorrect Or Inadequate Test Results (2456)

Patient Problem Hypoglycemia (1912)

Event Date 05/29/2018

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

Event Description

Customer called and reported that they received emergency medical assistance due to low blood glucose on (b)(6) 2018 with blood glucose of 24 mg/dl at the time of the incident.The customer experienced symptoms such as loss of consciousness.The customer was wearing the insulin pump during the incident.The customer stated they were having big sensor glucose versus blood glucose differences.Troubleshooting was not completed as the customer declined.The insulin pump will not be returned for analysis.

• Brand Name: 530G INSULIN PUMP MMT-551LNAS
• 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: 7604776
• MDR Text Key: 111148136
• Report Number: 3004209178-2018-82057
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169507739
• UDI-Public: (01)00643169507739
• 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: 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-551LNAS
• Device Catalogue Number: MMT-551LNAS
• Device Lot Number: A4551LNASJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/01/2018
• Date Device Manufactured: 06/16/2017
• 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: 61 YR
• Patient Weight: 234