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

Model Number MMT-551NAB

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Hyperglycemia (1905)

Event Date 04/28/2018

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 reported via phone call that they experienced high blood glucose levels of over 400 mg/dl.Customer¿s current blood glucose level was 161 mg/dl.Customer also experiences blood glucose level of 124 mg/dl.Customer was also reported sensor issue.The customer states that the difference between sensor glucose and blood glucose was not within range.Product was not returned for analysis.

Manufacturer Narrative

Device had unresponsive buttons due to flattened (creased) esc and act buttons dome switch.No unlocked lcd keypad connector noted.Unable to perform operating currents, self-test, a21 error test, rewind test, basic occlusion test, occlusion test, prime test, excessive no delivery test and displacement test or verify communicate to sensor simulator to confirm calibrate error alarm due to unresponsive button.(b)(4).

• Brand Name: 530G INSULIN PUMP MMT-551NAB
• 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: 7713222
• MDR Text Key: 114799243
• Report Number: 3004209178-2018-95091
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169503625
• UDI-Public: (01)00643169503625
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 07/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-551NAB
• Device Catalogue Number: MMT-551NAB
• Device Lot Number: A4551NABJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2015
• 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: SENSOR-MMT-7008
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Weight: 218