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

Model Number MMT-751NAL

Device Problem Device Displays Incorrect Message (2591)

Patient Problems Syncope (1610); Hyperglycemia (1905); Diabetic Ketoacidosis (2364)

Event Date 06/04/2017

Event Type  Injury  

Manufacturer Narrative

This mdr related to the puerto rico manufacturing site has been assigned a medwatch number from the medtronic minimed northridge site, per variance 5.Currently it is unknown whether or not the device may have caused or contributed to the event.The device has been returned, but not yet evaluated.Further information will follow once the analysis has been completed.No conclusion can be drawn at this time.

Event Description

Customer reported via phone call that they were hospitalized on (b)(6) 2017 due to diabetic ketoacidosis with a blood glucose of 951 mg/dl.The customer stated they were feeling ill the night before and had a virus and did not realize that they were not receiving any insulin.The customer passed out on the ground the next morning.The customer was still at the hospital at the time of call with a reading of 259 mg/dl.The customer was wearing the insulin pump at the time of hospitalization.The customer mentioned getting a low battery alert prior to high blood glucose episode.The customer did not complete troubleshooting.The insulin pump was replaced.The customer will return the product for analysis.

Manufacturer Narrative

All operating currents are within specification.No unexpected low battery or off no power alarms noted.Unit functioned properly.Unit passed functional test including displacement test, rewind, basic occlusion, occlusion, prime and excessive no delivery alarm test.Unit functioned properly.Unit was received with cracked case on display window corners, minor scratched lcd window, cracked reservoir tube, cracked reservoir tube lip, cracked belt clip slot and cracked battery tube threads.The insulin pump passed the delivery accuracy test.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: 530G INSULIN PUMP MMT-751NAL
• 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: 6689814
• MDR Text Key: 79170868
• Report Number: 2032227-2017-26277
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169404328
• UDI-Public: (01)00643169404328
• 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,Followup
• Report Date: 07/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-751NAL
• Device Catalogue Number: MMT-751NAL
• Device Lot Number: A2751NALJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Hospitalization
• Patient Age: 60 YR