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

Model Number	MMT-522NAB
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/10/2017
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 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
The customer reported via phone call that the insulin pump alarmed compromised force sensor system.The customer¿s blood glucose level was 122 mg/dl at the time of the incident.The customer reported having a problem, trying to rewind and prime the insulin pump.The customer reported the insulin was "squirting out" during the manual prime process.The drive support disk is normal slightly indented.The customer did troubleshoot the issue.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 prime during the basic occlusion test due to loose and protruded drive support disk.We were unable to perform operating currents, unexpected restart error test, self-test, basic occlusion test, occlusion test, prime test, excessive no delivery test or verify rewind alarm due to prime alarm.The device had minor scratched lcd window, cracked lcd window, cracked case at display window corners, broken battery tube threads, broken reservoir tube lip, cracked reservoir tube, cracked reservoir tube window, cracked case at reservoir tube window corners, missing end cap sticker and corroded battery tube.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522NAB
• 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: 6835012
• Report Number: 2032227-2017-43218
• Device Sequence Number: 19189955
• Product Code: OYC
• UDI-Device Identifier: 00613994372024
• UDI-Public: (01)00613994372024
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 01/10/2018

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-522NAB
• Device Catalogue Number: MMT-522NAB
• Device Lot Number: A4522NABJ
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/10/2017
• Supplement Date Received by Manufacturer: 12/21/2017
• Initial Report FDA Received Date: 08/31/2017
• Supplement Report FDA Received Date: 01/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 142