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	Hypoglycemia (1912)
Date of Event	05/30/2017
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 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
Customer called and reported that they got hospitalized due to low blood glucose on (b)(6) 2017, with blood glucose of 32 mg/dl at the time of the incident.The customer was priming the pump while connected and gave himself too much insulin.The customer was given glucose tablets to treat.The customer experienced symptoms such as loss of consciousness and stroke.The customer was not wearing the insulin pump during the incident within less than 48 hours.Troubleshooting was not completed.Customer had called earlier with a compromised force sensor alarm and a drive support cap that was sticking out.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Findings: all operating currents are within specification.No unexpected low batt or off no power alarms noted.Unit alarmed compromised force sensor system during basic occlusion test due to loose/protruded drive support disk.Unable to complete functional test including prime test, occlusion test and excessive no delivery alarms test due to compromised force sensor system alarm.Unit received with cracked case on display window corners, minor scratched lcd window, cracked reservoir tube lip, cracked battery tube threads, missing end cap sticker and loose drive support disk.

• 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: 6630085
• Report Number: 3004209178-2017-54116
• Device Sequence Number: 1083458
• Product Code: OYC
• UDI-Device Identifier: 00885074419800
• UDI-Public: (01)00885074419800(017)20091231
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 09/05/2017

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 Expiration Date: 12/31/2009
• Device Model Number: MMT-722NAB
• Device Catalogue Number: MMT-722NAB
• Device Lot Number: A1722NAB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2017
• Initial Date Received by Manufacturer: 05/30/2017
• Supplement Date Received by Manufacturer: 08/24/2017
• Initial Report FDA Received Date: 06/09/2017
• Supplement Report FDA Received Date: 09/05/2017
• 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: Hospitalization
• Patient Age: 58 YR
• Patient Weight: 215