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

Model Number	MMT-722LNAB
Medical Device Problem Code	Failure to Cycle (1142)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/15/2018
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 on (b)(6) 2018 that the insulin pump had a compromised force sensor alarm.Blood glucose level at the time of the incident was unknown.No symptoms were indicated and so no treatment necessary.Customer stated the device drive support cap is sticking out.Trouble shooting occurred but issue was not resolved.The customer was advised that the insulin pump would be replaced and agreed to return the device for analysis.
Additional Manufacturer Narrative
Insulin pump passed the displacement test but compromised force sensor system alarm during the basic occlusion test due to loose or protruded drive support disk.Unable to perform the occlusion,compromised force sensor system and excessive no delivery test due to compromised force sensor system alarm.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722LNAB
• 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: 7774967
• Report Number: 2032227-2018-12215
• Device Sequence Number: 11042406
• Product Code: OYC
• UDI-Device Identifier: 00613994287243
• UDI-Public: (01)00613994287243
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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,Followup
• Report Date (Section B): 03/05/2019

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-722LNAB
• Device Catalogue Number: MMT-722LNAB
• Device Lot Number: A000098493
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2018
• Initial Date Received by Manufacturer: 07/15/2018
• Supplement Date Received by Manufacturer: 03/04/2019
• Initial Report FDA Received Date: 08/10/2018
• Supplement Report FDA Received Date: 03/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 24 YR
• Patient Weight: 170