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

Model Number	MMT-722NAB
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	06/18/2017
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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.
Event or Problem Description
The customer reported via phone call that the insulin pump alarmed compromised force sensor system.The customer was assisted with troubleshooting.The customer's blood glucose level was 400mg/dl at the time of the incident.The customer treated the high with a syringe and declined troubleshooting for the high readings.The customer stated that the drive support cap was protruded.The customer also stated that they recalled pressing the cap while connected.The customer was advised that the insulin pump needed to be replaced and was advised to discontinue use of the insulin pump and to revert to the backup plan.The insulin pump will not be returned for analysis.
Additional Manufacturer Narrative
Unit was received with motor error alarm during the basic occlusion test due to loose/protruded drive support disk.Unable to perform basic occlusion test, occlusion test, prime/compromised force sensor system test, excessive no delivery test or verify compromised force sensor system alarm due to motor error alarm.Unit had minor scratched lcd window, cracked 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 INSULIN INFUSION PUMP MMT-722NAB
• 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: 6708958
• Report Number: 2032227-2017-28026
• Device Sequence Number: 11135542
• Product Code: OYC
• UDI-Device Identifier: 00613994312402
• UDI-Public: (01)00613994312402
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 03/02/2018

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-722NAB
• Device Catalogue Number: MMT-722NAB
• Device Lot Number: A3722NABJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2017
• Initial Date Received by Manufacturer: 06/18/2017
• Supplement Date Received by Manufacturer: 02/15/2018
• Initial Report FDA Received Date: 07/12/2017
• Supplement Report FDA Received Date: 03/02/2018
• 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: 42 YR
• Patient Weight: 146