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
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	10/27/2016
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
The customer reported via phone call that their insulin pump was damaged.The customer's blood glucose was unknown at the time of incident.The reservoir compartment has been chipping off and that last night a big piece came off and now customer cannot get reservoir to stay in the pump.Customer has reverted to another pump blood glucose was 570 mg/dl, the customer used other pump to bolus blood glucose was 549 mg/dl.The customer was advised to discontinue use of the insulin pump and to revert to the back-up plan.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
The insulin pump had cracked case at display window corners, broken battery tube threads, cracked reservoir tube, reservoir tube lip completely broken off and test reservoir will not lock/click in place, minor scratched and cracked display window.Unable to perform the displacement test, basic occlusion and occlusion test due to reservoir tube lip anomaly.The insulin pump passed the operating currents measurement, self test, unexpected restart error test, prime and excessive no delivery tests.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523RNAS
• Common Device Name: PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• MDR Report Key: 6689395
• Report Number: 2032227-2017-26219
• Device Sequence Number: 1882510
• Product Code: OYC
• UDI-Device Identifier: 00613994918611
• UDI-Public: (01)00613994918611
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-523RNAS
• Device Catalogue Number: MMT-523RNAS
• Device Lot Number: A000204721
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2017
• Initial Date Received by Manufacturer: 06/10/2017
• Supplement Date Received by Manufacturer: 08/07/2017
• Initial Report FDA Received Date: 07/06/2017
• Supplement Report FDA Received Date: 08/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 80 YR
• Patient Weight: 138