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 Loss of Power (1475); Inaccurate Delivery (2339); Battery Problem (2885)

Patient Problem Hyperglycemia (1905)

Event Date 03/24/2017

Event Type  malfunction  

Manufacturer Narrative

Replace battery now alarm and power error alarm confirmed in the long trace.Detail trace analysis confirmed the pump alarmed replace battery now and then alarmed power error was triggered when backup battery loaded voltage (loaded vlith) was less than 3.5v for 4 consecutive hours due to connector resistance connector board.After disconnecting and reconnecting the internal battery connector at connector board.The insulin pump was monitored and functioned properly.The insulin 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, displacement test and the dat at 0.08900 inches.No delivery anomaly noted.The insulin pump was received with minor scratched lcd window, scratched case and pillowing keypad overlay.(b)(4).

Event Description

The customer reported via phone call that the insulin pump had battery issue, insulin issue and no power issue.The customer¿s blood glucose was 283 mg/dl at the time of the incident.The customer¿s blood glucose level was 101 mg/dl at the time of call.The customer thinks that there was a delivery anomaly as the customer feels the insulin pump was under delivering.The customer had symptom related to high blood glucose was feeling sick.The insulin pump was 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: 7043642
• MDR Text Key: 92534532
• Report Number: 2032227-2017-66880
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169656840
• UDI-Public: (01)00643169656840(017)20170331
• 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: 11/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2017
• Device Model Number: MMT-1715K
• Device Catalogue Number: MMT-1715K
• Device Lot Number: HG1CSXB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2016
• 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: 38 YR
• Patient Weight: 66