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	Hypoglycemia (1912)
Date of Event	08/15/2017
Type of Reportable Event	Serious Injury
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
Customer called to report that the insulin pump alarmed compromised forced sensor system during prime rewind process.Customer called to report that the drive support cap is sticking out of the insulin pump.Customer reported that the force sensor does not detect the reservoir.Customer's blood glucose reading was 51 mg/dl.Advised discontinuation of the insulin pump and revert to back up plan per health care professional.Product is being returned and replaced.
Additional Manufacturer Narrative
Insulin pump passed displacement test, prime test, excessive no delivery test, self test and error test.Unable to confirm compromised force sensor system alarm and unable to perform basic occlusion and occlusion test due to reservoir tube lip damage.The test reservoir does not stay locked in place due to reservoir tube lip damage.Pump passed all operating currents tested within the spec range and passed off no power test.Pump received with cracked battery tube thread, reservoir tube lip completely broken off, missing reservoir tube lip o-ring, cracked case near display window corners, cracked on display window, loose/protruded drive support disk and minor scratches on display window noted.

• 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: 6842313
• Report Number: 2032227-2017-44436
• Device Sequence Number: 684303
• Product Code: OYC
• UDI-Device Identifier: 00613994223739
• UDI-Public: (01)00613994223739(017)20091231
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): 11/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: A000093827
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2017
• Initial Date Received by Manufacturer: 08/15/2017
• Supplement Date Received by Manufacturer: 11/09/2017
• Initial Report FDA Received Date: 09/05/2017
• Supplement Report FDA Received Date: 11/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 70 YR
• Patient Weight: 145