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	No Consequences Or Impact To Patient (2199)
Date of Event	10/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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
The customer reported via phone call that the insulin pump alarmed compromised force sensor system and error alarms.The customer¿s blood glucose level was 233 mg/dl.The customer was advised that the insulin pump needed to be replaced and was advised to revert to the backup plan.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Insulin pump was received with loose/protruded drive support disk, minor scratched display window, cracked display window, cracked case at display window corners, cracked reservoir tube lip, broken belt clip slot and missing end cap sticker.Compromised force sensor system alarm during prime/compromised force sensor system test and motor error alarm during basic occlusion test due to loose/protruded drive support disk.Insulin pump passed displacement test.Unable to perform occlusion test and excessive no delivery test due to compromised force sensor system alarm.

• 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: 6993536
• Report Number: 2032227-2017-63226
• Device Sequence Number: 16468547
• Product Code: OYC
• UDI-Device Identifier: 00613994622587
• UDI-Public: (01)00613994622587
• 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,Followup
• Report Date (Section B): 03/05/2018

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-722NAH
• Device Catalogue Number: MMT-722NAH
• Device Lot Number: A2722NAHJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2017
• Initial Date Received by Manufacturer: 10/21/2017
• Supplement Date Received by Manufacturer: 02/19/2018
• Initial Report FDA Received Date: 11/01/2017
• Supplement Report FDA Received Date: 03/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 140