MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523RNAS; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number MMT-523RNAS

Device Problem Invalid Sensing (2293)

Patient Problem Hyperglycemia (1905)

Event Date 09/15/2017

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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.

Event Description

Customer reported via phone call that they were hospitalized with medium ketones on (b)(6) and high blood glucose readings of 647 mg/dl at the time of the hospitalization.Customer's blood glucose reading during the hospital stay was 647 mg/dl range.Customer's blood glucose reading at the time of the call was 300 mg/dl.Customer reported that highs were up and down since friday and they saw their highs were going down.Troubleshooting was performed and all settings appeared to be normal.The drive support cap was noted to be normal.Customer treated for high blood glucose with syringes.It was noted that the customer was off the insulin pump less than 48 hours prior to the hospitalization.Customer was not wearing the pump at time of hospitalization.Customer reports they have contacted their health care provider regarding the high blood glucose and the insulin pump is not expected to return for analysis.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523RNAS
• Type of Device: PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• Manufacturer (Section G): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• Manufacturer Contact: gerwin de graaff ; 18000 devonshire st.; northridge, CA 91325-1219
• MDR Report Key: 6895204
• MDR Text Key: 87443229
• Report Number: 2032227-2017-52966
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00643169221550
• UDI-Public: (01)00643169221550
• 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
• Report Date: 09/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-523RNAS
• Device Catalogue Number: MMT-523RNAS
• Device Lot Number: A000290041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/18/2017
• 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; Required Intervention
• Patient Age: 80 YR
• Patient Weight: 180