MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAL; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number MMT-723NAL

Device Problems Loose or Intermittent Connection (1371); Device Displays Incorrect Message (2591); Malposition of Device (2616)

Patient Problem Hyperglycemia (1905)

Event Date 05/03/2018

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 that the insulin pump received compromised force sensor system alarm, insulin was squirting out during the manual prime process and drive support cap was loose.The customer¿s blood glucose level was 386 mg/dl.The customer was treated with manual injection for high blood glucose level.The customer reported that the drive support cap was loose and it was able to push it in and found that it was sticking out.Customer was advised to discontinue use of the device and revert to a back-up plan.The customer was advised that the device would be replaced and agreed to return the insulin pump for analysis.

Manufacturer Narrative

Pump passed the displacement test but alarmed compromised force sensor system during the basic occlusion test due to loose/protruded drive support disk.Unable to perform the occlusion, prime and excessive no delivery test or verify prime/fill anomaly due to the compromised force sensor system alarm.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAL
• 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: 7536207
• MDR Text Key: 109106172
• Report Number: 3004209178-2018-73427
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00613994743916
• UDI-Public: (01)00613994743916
• 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: 07/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-723NAL
• Device Catalogue Number: MMT-723NAL
• Device Lot Number: A3723NALJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/13/2018
• 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: 59 YR
• Patient Weight: 68