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

Model Number MMT-551LNAS

Device Problems Inaccurate Delivery (2339); Device Operates Differently Than Expected (2913)

Patient Problem Hyperglycemia (1905)

Event Date 02/01/2018

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

The customer reported via phone call that the customer was hospitalized due to high blood glucose was over 550 mg/dl on (b)(6) 2018.The customer¿s blood glucose level was 315 mg/dl.The customer was treated with manual injection.It was reported that the pump insulin pump was not working and had not delivering insulin.The customer allege pump was under delivering because the insulin was not coming out.The customer was advised that replace and will send same model pump but in larger size.The customer was advised that same products will work with pump.The insulin pump will not be returned for analysis.

Manufacturer Narrative

Device passed the functional test, including the displacement test, rewind, basic occlusion test, occlusion test, prime or compromised force sensor system alarm test, excessive no delivery test and delivery accuracy test.No delivery anomaly noted.The stop current and run current measurement tests are within specification.Device also passed self test, off no power alarm test and unexpected restart error test.Device had intermittent button response on the esc and act buttons due to fattened dome switch (creased).During visual inspection, the keypad connector on the lcd was found locked properly.Device had cracked reservoir tube.

• Brand Name: 530G INSULIN PUMP MMT-551LNAS
• 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: 7265688
• MDR Text Key: 99875558
• Report Number: 3004209178-2018-50350
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169933033
• UDI-Public: (01)00643169933033
• 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: 06/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-551LNAS
• Device Catalogue Number: MMT-551LNAS
• Device Lot Number: A5551LNASJ
• 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: 05/15/2018
• 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): Hospitalization; Other
• Patient Age: 48 YR
• Patient Weight: 170