MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523NAP; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-523NAP
Health Effect - Clinical Codes	Hyperglycemia (1905); Hypoglycemia (1912)
Date of Event	05/17/2017
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
Customer reported via phone call that they experienced high blood glucose readings of 439 mg/dl due to treating with carbs for a low blood glucose reading of 51 mg/dl.Customer has treated the high blood glucose readings with the insulin pump.Customer mentioned that the button part of the insulin pump was cracked and coming off.Customer mentioned that he went swimming with the insulin pump and the device has been exposed to moisture.It was noted that the customer landed on the insulin pump when he got in the pool and the fluid was noticeable under the lcd window.Customer also mentioned having issues with the keypad.Customer was advised to discontinue use of the insulin pump and revert to a back up plan.Insulin pump is being returned for analysis.
Additional Manufacturer Narrative
The insulin pump was received with unresponsive buttons due to moisture damage at keypad traces.No button error alarm noted.Traces of moisture found at the electronic assembly per visual inspection.Unable to perform functional testing including the displacement, operating currents, unexpected restart error test, rewind, basic occlusion, occlusion, prime and excessive no delivery test due to unresponsive buttons.Unable to test for bolus anomaly due to unresponsive buttons.The insulin pump received with minor scratched lcd window, cracked case at the display window corners, missing reservoir tube o ring, cracked reservoir tube lip and missing end cap sticker.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523NAP
• Common Device Name: PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• MDR Report Key: 6638994
• Report Number: 3004209178-2017-55047
• Device Sequence Number: 19077332
• Product Code: OYC
• UDI-Device Identifier: 00643169077676
• UDI-Public: (01)00643169077676
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 07/31/2017

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-523NAP
• Device Catalogue Number: MMT-523NAP
• Device Lot Number: A7523NAPJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2017
• Initial Date Received by Manufacturer: 05/17/2017
• Supplement Date Received by Manufacturer: 07/21/2017
• Initial Report FDA Received Date: 06/13/2017
• Supplement Report FDA Received Date: 07/31/2017
• 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: 47 YR
• Patient Weight: 165