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 Problems Fluid/Blood Leak (1250); Sticking (1597); Device Displays Incorrect Message (2591); Reset Problem (3019)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/29/2018

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 was reported via phone call that; the insulin pump had prime rewind anomaly and the drive support cap was sticking out.The blood glucose was 220 mg/dl at the time of the incident.Customer stated that, the insulin was squirting out during the manual prime process.Customer reported that, the insulin squirting out during the prime process.Customer stated that, the motor did not slow down nor did numbers ramp up on the screen.The insulin pump got stuck on rewind loop could not verify if pump alarmed per customer.Troubleshooting determined that, the insulin pump should be replaced.The customer advised to discontinue use of the pump and revert to a back-up plan.The device will be returned for analysis.

Manufacturer Narrative

A test reservoir was installed and did not lock in place due to completely broken reservoir tube lip.Unable to perform rewind test, basic occlusion test, occlusion test, prime/delivery test, excessive no delivery test and displacement test or verify prime/fill anomaly due to completely broken reservoir tube lip.

• 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
• MDR Report Key: 7260458
• MDR Text Key: 99924975
• Report Number: 3004209178-2018-49761
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169404250
• UDI-Public: (01)00643169404250
• 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: 09/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• 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: 02/12/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/29/2018
• 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: 56 YR
• Patient Weight: 147