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	Hypoglycemia (1912)
Date of Event	05/18/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No button error alarm noted.However buttons did not respond due to corroded keypad traces.Insulin pump passed idle current test.Unable to perform run current test, self test, off no power test, unexpected restart error test, basic occlusion test, occlusion test, prime test, excessive no delivery test, displacement test due to button keypad anomaly.Insulin pump received with minor scratched display window, cracked case at display window corners, broken battery tube threads, cracked reservoir tube lip and cracked reservoir tube.
Event or Problem Description
Customer reported via phone call that they experienced low blood glucose levels of 52 mg/dl.The customer had symptoms such as sleeping and was perspiring from her low blood glucose.The customer was treated for the low blood glucose with juice.The customer stated the insulin pump alarmed button error.Advised to observe time clock for one minute to verify if time advances; found the time advances.The customer was advised that the insulin pump will need to be replaced.The customer was advised to disconnect from the insulin pump and revert to back-up plan.The insulin pump was returned for analysis.

• 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: 6703587
• Report Number: 2032227-2017-27543
• Device Sequence Number: 881923
• Product Code: OYC
• UDI-Device Identifier: 00613994918611
• UDI-Public: (01)00613994918611
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 07/11/2017

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: 05/25/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2017
• Initial Report FDA Received Date: 07/11/2017
• 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: 72 YR
• Patient Weight: 182