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

Model Number	MMT-722NAS
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/19/2017
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.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 had an unexpected alarm during normal use.Blood glucose level at the time of the incident was unknown.The insulin pump was stuck on rewind and could not get to history.The customer stated the alarm occurred during the rewind/prime sequence.The customer was advised to refer to back-up plan, per healthcare professional's instructions.The customer was advised that the insulin pump would be replaced and agreed to return the product for analysis.
Additional Manufacturer Narrative
Findings: no rewind anomaly noted.However, unit received motor error alarm during the basic occlusion test due to loose/protruded drive support disk.Unable to perform operating currents, unexpected alarm error test, self-test, basic occlusion test, occlusion test, prime test, excessive no delivery test or verify compromised forced sensor alarm due to motor error alarm.Unit had minor scratched lcd window, cracked lcd window, cracked case at display window corners, cracked battery tube threads, broken belt clip slot, broken reservoir tube lip, stained address/serial number label and stained end cap sticker.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722NAS
• 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: 6849864
• Report Number: 2032227-2017-45597
• Device Sequence Number: 10962759
• Product Code: OYC
• UDI-Device Identifier: 00613994223746
• UDI-Public: (01)00613994223746
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 11/28/2017

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-722NAS
• Device Catalogue Number: MMT-722NAS
• Device Lot Number: A000093830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2017
• Initial Date Received by Manufacturer: 08/19/2017
• Supplement Date Received by Manufacturer: 11/20/2017
• Initial Report FDA Received Date: 09/07/2017
• Supplement Report FDA Received Date: 11/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Weight: 206