MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722NAP; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-722NAP
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/13/2017
Type of Reportable Event	Malfunction
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
The customer reported via phone call that the insulin pump alarmed motor error several times.Customer's blood glucose level was 127 mg/dl.The drive support cap was protruded.Customer was advised to discontinue use of the device and revert to a backup plan.The customer was advised that the device would be replaced and agreed to return the product for analysis.
Additional Manufacturer Narrative
The insulin pump passed the displacement test.Unit received with motor error alarm during the basic occlusion test due to loose/protruded drive support disk.Unable to perform the unexpected restart error test, prime test, excessive no delivery test and occlusion test due to motor error alarm.Pump received with normal operating current.The insulin pump passed self test.The insulin pump passed off no power test.The insulin pump was received with minor scratched lcd window, loose drive support disk, cracked case at the display window corners, cracked belt clip slot, cracked battery tube threads, stained end cap sticker, broken reservoir tube lip and stained address/serial number label.
Additional Manufacturer Narrative
Findings: pump passed the displacement test.Unit received with motor error alarm during the basic occlusion test due to loose/protruded drive support disk.Unable to perform the unexpected alarm error test, prime test, excessive no delivery test and occlusion test due to motor error alarm.Pump received with normal operating current.Pump passed self test.Pump passed off no power test.Pump received with minor scratched lcd window, loose drive support disk, cracked case at the display window corners, cracked belt clip slot, cracked battery tube threads, stained end cap sticker, broken reservoir tube lip and stained address/serial number label.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722NAP
• Common Device Name: PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• MDR Report Key: 6765999
• Report Number: 2032227-2017-34136
• Device Sequence Number: 2064729
• Product Code: OYC
• UDI-Device Identifier: 00885074419824
• UDI-Public: (01)00885074419824(017)20091231
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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,Followup
• Report Date (Section B): 12/04/2017

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 Expiration Date: 12/31/2009
• Device Model Number: MMT-722NAP
• Device Catalogue Number: MMT-722NAP
• Device Lot Number: A1722NAP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2017
• Initial Date Received by Manufacturer: 07/13/2017
• Supplement Date Received by Manufacturer: 10/19/2017; 10/19/2017
• Initial Report FDA Received Date: 08/03/2017
• Supplement Report FDA Received Date: 10/24/2017; 12/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 41 YR