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

Model Number MMT-751NAB

Device Problems Break (1069); Crack (1135); Failure of Device to Self-Test (2937)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/01/2018

Event Type  malfunction  

Manufacturer Narrative

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 issues with motor error, failed battery test and physical damage.Blood glucose level at the time of the incident was not provided.The customer stated there were cracks around the battery compartment and around the screen.The customer declined to troubleshoot.The product will be returned for analysis.

Manufacturer Narrative

The device alarmed motor error during rewind due to moisture damaged the motor home switch.Unable to perform operating current test, unexpected restart error test or all functional testing including the displacement, rewind, basic occlusion, occlusion, prime/compromised force sensor system and excessive no delivery test or verify low battery, failed battery test, no delivery alarm due to motor error alarms.The device had cracked lcd window, cracked case at display window corner.No moisture damaged electronic assembly during visual inspection.

• Brand Name: 530G INSULIN PUMP MMT-751NAB
• 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: 7664146
• MDR Text Key: 113411958
• Report Number: 3004209178-2018-88402
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169404304
• UDI-Public: (01)00643169404304
• 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: 09/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-751NAB
• Device Catalogue Number: MMT-751NAB
• Device Lot Number: A3751NABJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2014
• 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: 24 YR
• Patient Weight: 172