MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522NAL; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-522NAL
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The pump passed operating current, however it was received with a broken off end cap.The pump was unable to perform unexpected restart alarm error, displacement, the basic occlusion, occlusion, prime/compromised force sensor system, excessive no delivery tests due to broken off end cap.The pump was received with a cracked case at the display window corner, reservoir tube lip, belt clip slot, reservoir tube window, and battery tube threads.There were also minor scratches on the lcd window.
Event or Problem Description
The customer reported via phone call that the insulin pump was damaged.The customer stated that the cover has fallen off and that wires were visible.It was added that the seal on the end had come undone as well and that the insulin pump was also stuck in the rewind function.Troubleshooting for the damage was performed.The customer's blood glucose level was unknown at the time of the incident.The customer stated that there was also a crack in addition to the damaged mentioned but also stated that they did not know any specific events on how the damages occurred.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 was returned for analysis.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522NAL
• 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: 6899233
• Report Number: 2032227-2017-53614
• Device Sequence Number: 1089998
• Product Code: OYC
• UDI-Device Identifier: 00613994402110
• UDI-Public: (01)00613994402110
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/27/2017

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-522NAL
• Device Catalogue Number: MMT-522NAL
• Device Lot Number: A5522NALJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2017
• Initial Report FDA Received Date: 09/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 77