MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722NAH; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-722NAH
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	05/22/2017
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.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.(b)(4).
Event or Problem Description
The customer reported via phone call that the insulin pump alarmed compromised force sensor system during the rewind/prime sequence.Customer's blood glucose level was 389 mg/dl.Customer was advised to discontinue use of the device and revert to a backup plan.The customer was advised that the device would be replaced and agreed to return the product for analysis.
Additional Manufacturer Narrative
Compromised force sensor system alarm during basic occlusion test due to faulty force sensor resistor.Pump passed idle current test, run current test, displacement test and rewind.Unable to perform self test, off no power test, unexpected restart error test, occlusion test, prime test and excessive no delivery test due to compromised force sensor system alarm.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.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722NAH
• 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: 6652524
• Report Number: 2032227-2017-21722
• Device Sequence Number: 16513610
• Product Code: OYC
• UDI-Device Identifier: 00613994622587
• UDI-Public: (01)00613994622587
• 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): 07/24/2017

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-722NAH
• Device Catalogue Number: MMT-722NAH
• Device Lot Number: A2722NAHJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2017
• Initial Date Received by Manufacturer: 05/22/2017
• Supplement Date Received by Manufacturer: 07/14/2017
• Initial Report FDA Received Date: 06/19/2017
• Supplement Report FDA Received Date: 07/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Weight: 108