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); Device Displays Incorrect Message (2591)

Patient Problem Hyperglycemia (1905)

Event Date 01/20/2018

Event Type  Injury  

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

Customer reported via phone call that they had high blood glucose values and had a compromised force sensor system alarm.Customer¿s blood glucose value at time of incident was 420 mg/dl.Customer already treated high blood glucose using an injection and customer declined to do the troubleshooting for the high blood glucose.Customer stated that insulin was squirting out during the manual prime process.The drive support cap was normal.Insulin pump will not be returned for analysis.

Manufacturer Narrative

Device passed the displacement test but compromised force sensor system alarm during the basic occlusion test due to loose or protruded drive support disk.Unable to perform the occlusion, prime or compromised force sensor system alarm and excessive no delivery test due to compromised force sensor system alarm.Device received with cracked battery tube threads, cracked lcd window, minor scratched lcd window, cracked reservoir tube lip, cracked case display window corner, stained end cap sticker, stained address or serial number label, cracked belt clip slot and cracked case reservoir tube window corner.

• 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: 7229820
• MDR Text Key: 98628456
• Report Number: 3004209178-2018-47306
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169503656
• UDI-Public: (01)00643169503656
• 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: 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-551NAP
• Device Catalogue Number: MMT-551NAP
• Device Lot Number: A4551NAPJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/11/2018
• 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 Outcome(s): Other
• Patient Age: 54 YR
• Patient Weight: 150