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 No Display/Image (1183); Display or Visual Feedback Problem (1184); Device Difficult to Program or Calibrate (1496); Moisture or Humidity Problem (2986); Patient Device Interaction Problem (4001)

Patient Problem Pregnancy (3193)

Event Date 08/17/2019

Event Type  malfunction  

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 reported via phone call that the insulin pump had blank display.The customer's blood glucose value was 233 mg/dl.Customer stated that the customer went to swimming and insulin pump exposed to moisture.Customer stated screen was flashing and also buttons were not responding.Customer advised the insulin pump will need to be replaced.Advised to discontinue use of the insulin pump and revert to a back-up plan.The insulin pump will be returned for analysis.

Manufacturer Narrative

Device passed the rewind test, prime or seating test, basic occlusion test and force sensor test.Device failed the sleep current test and active current test due to moisture damage on the electronic assembly.Blank display not confirmed.Device received with intermittent keypad unresponsiveness due to moisture damage on the electronic assembly.Missing segments or partial display not confirmed.Device failed the self test due to no back light caused by moisture damage on the electronic assembly.Device received with missing retainer and reservoir tube o-ring.Unable to perform the displacement test and p-cap or reservoir will not lock properly due to missing retainer.Device received with cracked belt clip rail case corner.Device received with pillowing keypad overlay.Device received with label damage or faded.

• 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 ; 8185464805
• MDR Report Key: 8930600
• MDR Text Key: 155524443
• Report Number: 2032227-2019-52968
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169656840
• UDI-Public: (01)00643169656840(17)180212
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 10/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/12/2018
• Device Model Number: MMT-1715K
• Device Catalogue Number: MMT-1715K
• Device Lot Number: HG205T8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2019
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/24/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2017
• 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 Age: 30 YR
• Patient Weight: 50