MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PUMP MMT-1715KM 630G 3ML BLACK MEDI ; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-1715KM

Device Problem False Reading From Device Non-Compliance (1228)

Patient Problem Hyperglycemia (1905)

Event Date 12/08/2017

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

The customer's spouse reported via phone call the patient¿s the blood glucose was high and the sensor had inaccurate readings that triggered threshold suspend alarm.The customer¿s blood glucose was 150 mg/dl and the sensor glucose was 50 mg/dl at the time of the incident.The customer reported that the last 2 sensors were reading off.He drank orange juice and their blood glucose level ended up going up to 500 mg/dl as it was wrong.The customer treated it with manual injection and insulin pump.Now today he had the same issues.The insulin pump was shutting off his basal and can¿t get it on or shut the sensor off.Blood glucose was 129 mg/dl and sensor glucose was 83 mg/dl.Insulin pump was down in 50 mg/dl range.Previously blood glucose was 120 mg/dl, 152 mg/dl, 172 mg/dl, and 112 mg/dl.Previously blood glucose was 439 mg/dl.Insulin pump suspended on low.Sensor glucose and blood glucose difference was not within acceptable range.Previously blood glucose was 154 mg/dl and sensor glucose was 137 mg/dl.Insulin delivery was suspended due to sensor glucose values of 75 mg/dl.Suspend on low limit in sensor settings was 75 mg/dl.The sensor and insulin pump will not be returned for analysis.

• Brand Name: PUMP MMT-1715KM 630G 3ML BLACK MEDI
• 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: 7144567
• MDR Text Key: 95719382
• Report Number: 2032227-2017-76561
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169873834
• UDI-Public: (01)00643169873834
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 12/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-1715KM
• Device Catalogue Number: MMT-1715KM
• Device Lot Number: HG1LP3W
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/11/2017
• Date Device Manufactured: 01/20/2017
• 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: 84 YR
• Patient Weight: 215