MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 630G INSULIN PUMP MMT-1715K 630G BLACK MG; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-1715K

Device Problems Device Operates Differently Than Expected (2913); Programming Issue (3014)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Head Injury (1879); Hypoglycemia (1912); Injury (2348); Loss of consciousness (2418)

Event Date 05/15/2017

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 that they experienced several low blood glucose levels and has fallen, hurt themselves, and lost consciousness.The customer stated that they had a broken thumb, big knot on the head, sprained shoulder and rotator cuff, and broken toes.The customer was assisted with low blood glucose troubleshooting.The customer's blood glucose level was 55mg/dl at the time of the incident and 123mg/dl during the call.The customer was treated for the low blood glucose with glucagon shots.The customer stated that they went to the hospital for the injuries acquired due to low readings.The insulin pump's programming was inaccurate and the customer was assisted with correcting the time.The customer also stated that the reservoir was showing the same amount of insulin as shown on the status screen and that there was lifestyle changes.The customer was advised to contact healthcare professional to discuss possible cause of low blood glucose and to monitor insulin pump.The customer stated that they were going to the hospital.The customer went on (b)(6) 2017 at 10:45 p.M.With a blood glucose of 233mg/dl and was wearing the insulin pump.The product will not be returned for analysis.

• Brand Name: 630G INSULIN PUMP MMT-1715K 630G BLACK MG
• 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: 6660008
• MDR Text Key: 78176496
• Report Number: 2032227-2017-22707
• Device Sequence Number: 1
• Product Code: OZO
• 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: 06/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-1715K
• Device Catalogue Number: MMT-1715K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/27/2017
• 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: 56 YR
• Patient Weight: 183