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

Model Number MMT-551NAL

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912)

Event Date 06/19/2017

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

Event Description

Customer reported via phone call low blood glucose levels.Customer¿s blood glucose level was 47 mg/dl.Customer mentioned they ended up in the intensive care unit with diabetic ketoacidosis in 2014.Customer advised they put the insulin pump on suspend since they were low and as a result their blood glucose level jumped to 399 mg/dl.Customer performed and passed the self-test.Customer was advised to monitor their insulin pump and blood glucose levels.

• Brand Name: 530G INSULIN PUMP MMT-551NAL
• 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: 6723540
• MDR Text Key: 80379475
• Report Number: 2032227-2017-29601
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169503649
• UDI-Public: (01)00643169503649
• 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: 07/18/2017

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-551NAL
• Device Catalogue Number: MMT-551NAL
• Device Lot Number: A4551NALJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/22/2017
• Initial Date FDA Received: 07/18/2017
• 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): Other
• Patient Age: 56 YR
• Patient Weight: 138