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

Model Number	MMT-722RNAL
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/21/2017
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 compromised force sensor system.The customer¿s blood glucose level was unknown at the time of the incident.Customer reported that his battery was low, and then he changed the battery, and when the insulin ran out, he changed the infusion set, and as he was filling tubing he got gets compromised force sensor system.The customer stated that the drive support cap was flush.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
Motor error alarm during the basic occlusion test due to faulty force sensor resistor.Unable to confirm compromised force sensor system alarm due to motor error alarm.Pump passed displacement test, self test, off no power test and all operating currents tested within the specification range.Pump was monitored and tested with no low battery alert noted.Pump received with corroded battery tube, broken belt clip slot, cracked reservoir tube lip, cracked case near display window corners, cracked on display window and minor scratches on display window noted.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722RNAL
• 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: 6901112
• Report Number: 2032227-2017-53907
• Device Sequence Number: 1011464
• Product Code: OYC
• UDI-Device Identifier: 00613994409171
• UDI-Public: (01)00613994409171
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 03/20/2018

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-722RNAL
• Device Catalogue Number: MMT-722RNAL
• Device Lot Number: A000114564
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2017
• Initial Date Received by Manufacturer: 09/21/2017
• Supplement Date Received by Manufacturer: 03/07/2018
• Initial Report FDA Received Date: 09/28/2017
• Supplement Report FDA Received Date: 03/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Patient Weight: 165