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

Model Number	MMT-523NAH
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	08/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 reported via phone call the insulin pump had a keypad anomaly.The customer¿s blood glucose was 570 mg/dl at the time of incident.Customer stated that the insulin pump alarmed battery out limit and unable to clear the alarm due to unresponsive buttons.Customer stated that the insulin pump was exposed to moisture that could have led to keypad anomaly.Keypad anomaly troubleshooting was performed and confirmed that time is advancing.Customer also reported to have experienced a high blood glucose of 570 mg/dl and treated with manual injection.Customer declined high blood glucose troubleshooting.Customer's blood glucose reading was at 217 mg/dl the morning prior to call.The customer was advised to discontinue use of pump and revert to back-up plan.The insulin pump is being replaced and is expected to return for analysis.
Additional Manufacturer Narrative
Findings: unit received with button error alarm and had unresponsive bolus express, escape and act buttons due to corroded keypad traces.Unable to perform operating currents, self-test, unexpected alarm error test, rewind test, basic occlusion test, occlusion test, prime/a33 test, excessive no delivery test and displacement test or verify battery out limit alarm due to unresponsive button.Also, unit had moisture damage on electronic assembly and motor home switch during visual inspection.Unit had minor scratched lcd window, cracked case at display window corners, cracked battery tube threads, cracked reservoir tube lip, stained address/serial number label and stained end cap sticker.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523NAH
• 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: 6837819
• Report Number: 2032227-2017-43720
• Device Sequence Number: 761125
• Product Code: OYC
• UDI-Device Identifier: 00613994743855
• UDI-Public: (01)00613994743855
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 11/22/2017

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-523NAH
• Device Catalogue Number: MMT-523NAH
• Device Lot Number: A3523NAHJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2017
• Initial Date Received by Manufacturer: 08/16/2017
• Supplement Date Received by Manufacturer: 11/14/2017
• Initial Report FDA Received Date: 09/01/2017
• Supplement Report FDA Received Date: 11/22/2017
• 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: 60 YR
• Patient Weight: 180