MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-751NAS; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-751NAS

Device Problems Component Falling (1105); No Display/Image (1183); Loss of Power (1475); Improper or Incorrect Procedure or Method (2017); Moisture or Humidity Problem (2986)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/19/2017

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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.

Event Description

The customer reported via phone call that her pump has a blank display.She said that, the day before, the pump had counted down and then shut off.The customer said that she changed the battery, that the pump turned on for a little bit, stayed on overnight and had shut off by the morning of the call.The customer said that her blood glucose was 120 mg/dl before her pump had first lost power.During blank display troubleshooting, the customer said that the pump had been dropped occasionally and the only moisture that it had been exposed to was sweat.She said that the contacts on the battery cap are damaged.She was advised that a replacement battery cap would be sent to her and that she should revert to a back-up plan per her doctor¿s orders until the replacement battery cap arrives.The display did not return.The customer was advised that a damaged battery cap could lose and gain connection to the battery and cause the battery to drain.The insulin pump will not be returning for analysis.

• Brand Name: 530G INSULIN PUMP MMT-751NAS
• 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: 6799474
• MDR Text Key: 82887437
• Report Number: 2032227-2017-37472
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169503717
• UDI-Public: (01)00643169503717
• 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: 08/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-751NAS
• Device Catalogue Number: MMT-751NAS
• Device Lot Number: A4751NASJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/20/2017
• Initial Date FDA Received: 08/16/2017
• 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: 36 YR
• Patient Weight: 118