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

Model Number	MMT-523LNAH
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/04/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The customer was reported via phone call that, the customer received with unexpected restart alarm.The blood glucose was unknown at the time of the incident.Blood glucose was 227mg/dl.Customer called in stated that her pump went off, she changed battery, and the battery is full but it says the reservoir is blank.Performing troubleshoot and the unexpected restart alarm occurred after battery change.Customer states a temp basal was not programmed before the unexpected restart alarm occurred.Customer advised to replace the insulin pump.Customer advised to monitor the pump and that patient may continue to wear the pump until replacement arrives.The insulin pump will not be returned for analysis.
Additional Manufacturer Narrative
Insulin pump passed the operating currents, self test and displacement test.No blank display anomaly and no unexpected restart alarm noted during test.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523LNAH
• 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: 7042337
• Report Number: 2032227-2017-66662
• Device Sequence Number: 13928548
• Product Code: OYC
• UDI-Device Identifier: 00613994748812
• UDI-Public: (01)00613994748812
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): 08/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-523LNAH
• Device Catalogue Number: MMT-523LNAH
• Device Lot Number: A000168839
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2018
• Initial Date Received by Manufacturer: 11/04/2017
• Supplement Date Received by Manufacturer: 07/18/2018
• Initial Report FDA Received Date: 11/17/2017
• Supplement Report FDA Received Date: 08/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 123