MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PUMP MMT-1714K 630G BLACK MMOL CANADA; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-1714K

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Hypoglycemia (1912); Seizures (2063); Loss of consciousness (2418)

Event Date 07/28/2018

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 called and reported that they received emergency medical assistance and got hospitalized due to low blood glucose on (b)(6) 2018 with blood glucose of 38 mg/dl at the time of the incident.The customer was at 180 mg/dl at the time of the call.The customer was given intravenous fluids to treat.The customer experienced symptoms such as a seizure and loss of consciousness.The customer was wearing the insulin pump during the incident.The customer stated they uploaded the pump and it showed no activity after (b)(6) 2018, yet they had symptoms suggesting the pump had over delivered.Troubleshooting was not completed as this was a past event.The insulin pump will not be returned for analysis.

• Brand Name: PUMP MMT-1714K 630G BLACK MMOL CANADA
• 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: 7974177
• MDR Text Key: 123984172
• Report Number: 2032227-2018-44479
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169782396
• UDI-Public: (01)00643169782396
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-1714K
• Device Catalogue Number: MMT-1714K
• Device Lot Number: HG2DWNF
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/19/2018
• Date Device Manufactured: 03/14/2018
• 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: UNOMED INFS SETFRN-UNK-RSRVROZP-MMT-7020-SNSR
• Patient Outcome(s): Hospitalization