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

Model Number MMT-551NAB

Device Problem Fluid Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/12/2017

Event Type  malfunction  

Manufacturer Narrative

The insulin pump passed operating current, displacement test but the compromised force sensor system alarm occurred during the basic occlusion test due to loose/protruded drive support disk. Unable to perform the occlusion, prime/compromised force sensor system and excessive no delivery test or verify prime/fill anomaly and rewind anomaly due to compromised force sensor system alarm. The following physical damage was noted: cracked case at the display window corner, minor broken reservoir tube lip, minor scratched lcd window, missing end cap sticker, cracked case reservoir tube window corner and minor broken battery tube threads. No moisture damage on the lcd board, mother board, interface board, rf board, motor, vibrator motor and battery tube assembly during visual inspection noted.

Event Description

The customer's parent reported via phone call that they received compromised force sensor system alarm. The customer's blood glucose was 115 mg/dl at the time of incident. The caller reported that the insulin was squirting out during manual prime process. The insulin pump was returned for analysis.

• Brand Name: 530G INSULIN PUMP MMT-551NAB
• 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: 7671990
• MDR Text Key: 113628845
• Report Number: 3004209178-2018-89376
• Device Sequence Number: 1
• Product Code: OZO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 07/09/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 07/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: MMT-551NAB
• Device Catalogue Number: MMT-551NAB
• Device Lot Number: A2551NABJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2017

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/12/2017
• 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: Unkown