MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723RNAL; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number MMT-723RNAL

Device Problems Break (1069); Failure to Deliver (2338); Naturally Worn (2988)

Patient Problem Hyperglycemia (1905)

Event Date 01/13/2017

Event Type  malfunction  

Manufacturer Narrative

Currently it is unknown whether or not the device may have caused or contributed to the event.The device has been returned, but not yet evaluated.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 when they try to enter a bolus in their insulin pump, it does not deliver insulin.Their blood glucose is 294 mg/dl.The customer mentioned that they were in the hospital for a few weeks but it was not diabetes related.They stated that while they were in the hospital, they tried checking their bolus but did not receive any insulin.The customer mentioned that they have had issues downloading their readings at home.They also mentioned that their pump does not alarm and that their insulin pump does not show any alarms in the history.They mention that the down arrow is worn down to the point that the metal is showing and that there is damage to the battery cap.The customer performed the self-test on the insulin pump and it passed.The customer was advised to revert to the back-up plan.The insulin pump was returned for analysis.

Manufacturer Narrative

Findings: pump passed all functional testing, including idle current test, run current test, self test, off no power test, unexpected restart alarm error test, basic occlusion test, occlusion test, prime test, excessive no delivery test, displacement test and rewind test.No excessive no delivery alarm noted.Pump programmed with multiple bolus deliveries and all registered properly in the bolus history noted.No bolus delivery anomaly noted.Pump passed the inches.Pump received with minor scratched display window, cracked case at display window corners, cracked battery tube threads, cracked reservoir tube lip, cracked belt clip slot and keypad overlay worn-out.A complete analysis and testing of the insulin pump showed that it was functioning properly and passed all functional testing.After testing it was concluded that the device operated within specifications.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723RNAL
• 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: 6701916
• MDR Text Key: 79896127
• Report Number: 2032227-2017-27423
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00643169221482
• UDI-Public: (01)00643169221482
• 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: 09/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-723RNAL
• Device Catalogue Number: MMT-723RNAL
• Device Lot Number: A000290380
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/25/2017
• 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: 67 YR
• Patient Weight: 274