MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-754LWWL; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number MMT-754LWWL

Device Problems Break (1069); Positioning Problem (3009)

Patient Problem Hyperglycemia (1905)

Event Date 02/10/2018

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

It was reported that the reservoir ring was damaged and small piece was missing.The customer¿s blood glucose level was 300 mg/dl.The customer also reported that the reservoir was able to lock but barely in place when inserted in insulin pump.The insulin pump will be returned for analysis.

Manufacturer Narrative

Pump had cracked battery tube threads, reservoir tube lip almost completely broken off and test reservoir unable to lock into place, broken belt clip slot, minor scratched display window and stained address/serial number label.Pump passed the displacement test, prime and excessive no delivery test.Unable to perform the rewind, basic occlusion and occlusion test due to reservoir tube lip anomaly.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-754LWWL
• Type of Device: PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
• 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: 7302835
• MDR Text Key: 101156741
• Report Number: 3004209178-2018-53628
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00643169515727
• UDI-Public: (01)00643169515727
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-754LWWL
• Device Catalogue Number: MMT-754LWWL
• Device Lot Number: A2754LWWLJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/31/2018
• 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