MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-551NAP; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-551NAP

Device Problems Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/09/2018

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 alarmed compromised force sensor system.The customer¿s blood glucose level was 178 mg/dl at the time of the incident.The customer reported that she was just reloading the pump.When she did it pushed, all the insulin out.When customer was priming her tubing and the insulin was squirting out instead of dripping.Customer states insulin is squirting out during the manual prime process.Customer states the drive support cap is flush.The customer was advised that the insulin pump needed to be replaced and was advised to discontinue use of the insulin pump and to revert to the backup plan.The insulin pump will be returned for analysis.

Manufacturer Narrative

Compromised force sensor system alarm during the basic occlusion test due to loose or protruded drive support disk.Device received with corroded battery tube noted.No moisture damage on electronics and motor assembly noted.

• Brand Name: 530G INSULIN PUMP MMT-551NAP
• 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: 7287944
• MDR Text Key: 100672758
• Report Number: 3004209178-2018-52477
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169404281
• UDI-Public: (01)00643169404281
• 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: 08/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-551NAP
• Device Catalogue Number: MMT-551NAP
• Device Lot Number: A3551NAPJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/05/2018
• 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: 22 YR
• Patient Weight: 145