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

Model Number MMT-751LNAL

Device Problems Fluid/Blood Leak (1250); Device Displays Incorrect Message (2591); Reset Problem (3019)

Patient Problem Hyperglycemia (1905)

Event Date 04/24/2018

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 the insulin pump alarmed motor error.The customer¿s blood glucose level was 300 mg/dl at the time of the incident.The customer stated that the insulin pump alarmed motor error and the insulin was squirting out during rewind.The customer stated that the drive support cap was normal and that the insulin pump was not exposed to high magnetic fields and was not able to complete the rewind process.The customer was advised to discontinue use of the insulin pump and to revert to the back-up plan.The insulin pump is being replaced and is expected to return for analysis.

Manufacturer Narrative

Insulin pump passed the displacement test however compromised forced sensor system alarm during compromised forced sensor system test at 4 lbs.And motor error alarm during the basic occlusion test due to loose or protruded drive support disk.The motor was tested outside of the device and passed.Unable to verify no delivery alarm and prime anomaly due to compromised forced sensor system alarm noted.

• Brand Name: 530G INSULIN PUMP MMT-751LNAL
• 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: 7528931
• MDR Text Key: 108807337
• Report Number: 3004209178-2018-72900
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169507760
• UDI-Public: (01)00643169507760
• 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: 12/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-751LNAL
• Device Catalogue Number: MMT-751LNAL
• Device Lot Number: A4751LNALJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/05/2018
• 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 Age: 27 YR
• Patient Weight: 180