MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-751LNAL; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-751LNAL

Device Problem Device Alarm System (1012)

Patient Problems Hyperglycemia (1905); Renal Failure (2041)

Event Date 02/25/2019

Event Type  malfunction  

Manufacturer Narrative

Unit received alarm during basic occlusion test due to faulty fsr (gold).Unable to perform basic occlusion test, occlusion test, prime test, excessive no delivery test due to alarm.However, unit passed rewind test and displacement test.

Event Description

Customer reported via phone call that the insulin pump does not notify when insulin was not being delivered and resulted a high blood glucose value.Customer's blood glucose value was over 200 mg/dl.Insulin pump was returned for analysis.

• Brand Name: 530G INSULIN PUMP MMT-751LNAL
• 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: 9582531
• MDR Text Key: 174951862
• Report Number: 3004209178-2020-54914
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169507760
• UDI-Public: (01)00643169507760
• 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: Other
• Type of Report: Initial
• Report Date: 01/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-751LNAL
• Device Catalogue Number: MMT-751LNAL
• Device Lot Number: A4751LNALJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2019
• Date Manufacturer Received: 01/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2016
• 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: 52 YR