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	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/23/2012
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Pump passed self test and unexpected restart error test.Pump passed all operating currents tested within the specification range and passed off no power test.Unable to perform displacement test, rewind test, basic occlusion test, prime/delivery test, excessive no delivery test and occlusion test due to detached end cap.Pump was monitored and tested with no hot or burn battery noted.Pump received with broken battery tube thread, corroded battery tube, cracked reservoir tube lip, cracked reservoir tube, cracked reservoir tube window, cracked case near display window corners and minor scratches on display window noted.No burn damage noted on electronics assembly.
Event or Problem Description
The customer's parent reported via phone call that their insulin pump was damaged.The customer¿s blood glucose level was unknown at the time of the incident.Customer's parent stated the device had cracks and scratches near the battery compartment and was overheating, the customer was advised to discontinue use of the insulin pump and to revert to the back-up plan.The insulin pump was returned for analysis.

• 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: 6761203
• Report Number: 2032227-2017-33372
• Device Sequence Number: 1707625
• Product Code: OYC
• UDI-Device Identifier: 00613994373113
• UDI-Public: (01)00613994373113
• 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: other
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date (Section B): 08/02/2017

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-722NAB
• Device Catalogue Number: MMT-722NAB
• Device Lot Number: A4722NABJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2017
• Initial Report FDA Received Date: 08/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 26 YR
• Patient Weight: 150