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 Nonstandard Device (1420); Improper or Incorrect Procedure or Method (2017)

Patient Problem Hypoglycemia (1912)

Event Date 10/08/2017

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.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.

Event Description

The customer's parent reported via phone call that the customer had experienced multiple issues of severe low blood glucose values, including an incident in (b)(6) 2017 that required emt assistance.Prior to the june hypoglycemic incident, the customer was playing basketball and wearing the insulin pump.The customer experienced convulsions due to the low blood glucose.The patient was treated by ems and was not taken to the hospital.Additionally, the customer experienced a low blood glucose on (b)(6) 2017.He was given 64 ounces of (b)(6) and his blood glucose increased to 30 mg/dl.He also treated with glucose tablets.The caller believed that the insulin pump was over-delivering.During troubleshooting it was confirmed that the device programming was accurate.The insulin pump had not been wore during an mri or in proximity to powerful magnetic fields.The caller also mentioned that they had been re-using reservoirs, and the caller was advised against re-using consumables.The customer also had multiple boxes of infusion sets, one of which were specified for product recall.The insulin pump will be returned for analysis.

Manufacturer Narrative

Pump passed the functional test, including the self test, sleep current measurement, active current measurement, rewind test, prime/seating test, basic occlusion test, occlusion test, force sensor test and displacement test.Unit functioning properly.No delivery anomaly noted during testing.Unit received with minor scratched lcd window and cracked retainer.A complete analysis and testing of the insulin pump showed that it was functioning properly and passed all functional testing.After testing it was concluded that the device operated within specifications.

• 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: 6953365
• MDR Text Key: 89455415
• Report Number: 2032227-2017-58993
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169656840
• UDI-Public: (01)00643169656840
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 12/27/2017

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-1715K
• Device Catalogue Number: MMT-1715K
• Device Lot Number: HG1GJJH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2017
• Initial Date Manufacturer Received: 10/08/2017
• Initial Date FDA Received: 10/16/2017
• Supplement Dates Manufacturer Received: 12/12/2017
• Supplement Dates FDA Received: 12/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2016
• 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 Age: 17 YR
• Patient Weight: 168