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

Model Number	MMT-522NAP
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/04/2017
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 was exposed to moisture and was broken.The customer was assisted with troubleshooting.The customer¿s blood glucose was 88 mg/dl at the time of the incident.The customer stated that exposure was pool water and that there was fluid under the lcd display.The customer also added that the insulin pump had some cracks.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 be returned for analysis.
Additional Manufacturer Narrative
The device alarmed motor error during rewind due to corroded the motor home switch.Also, had moisture damage electronic assembly during visual inspection.We were unable to perform operating current test, unexpected restart error test or all functional testing including the displacement, rewind, basic occlusion, occlusion, prime and excessive no delivery test due to motor error alarms.The device had minor scratched lcd window, cracked lcd window, cracked battery tube threads, broken reservoir tube lip, cracked case at display window corners, cracked reservoir tube window, cracked case at reservoir tube window corners and missing end cap sticker.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522NAP
• 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: 6873616
• Report Number: 2032227-2017-49430
• Device Sequence Number: 656262
• Product Code: OYC
• UDI-Device Identifier: 00613994402103
• UDI-Public: (01)00613994402103
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 12/26/2017

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-522NAP
• Device Catalogue Number: MMT-522NAP
• Device Lot Number: A5522NAPJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2017
• Initial Date Received by Manufacturer: 09/04/2017
• Supplement Date Received by Manufacturer: 12/11/2017
• Initial Report FDA Received Date: 09/18/2017
• Supplement Report FDA Received Date: 12/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Weight: 173