MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723KNS; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-723KNS
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	04/24/2017
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
Customer's mother reported via phone call that the customer experienced low blood glucose levels of 48 mg/dl.The customer stated the drive support cap was loose.The caller also stated insulin squirted out a lot.The customer was treated for the low blood glucose with manual injections.Customer's blood glucose level was 202 mgdl at the time of the call.The customer was assisted with troubleshooting.The product will be returned for analysis.
Additional Manufacturer Narrative
The insulin pump passed operating current, unexpected restart error test, displacement test but compromised force sensor system alarm during the basic occlusion test due to loose/protruded drive support disk.Unable to perform the occlusion, prime and excessive no delivery test or verify prime/fill anomaly due to compromised force sensor system alarm.Pump received with cracked case at the display window corner, cracked reservoir tube lip, minor scratched lcd window, stained end cap sticker, cracked belt clip slot and cracked battery tube threads.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723KNS
• 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: 6684377
• Report Number: 2032227-2017-25771
• Device Sequence Number: 985162
• Product Code: OYC
• UDI-Device Identifier: 00613994743831
• UDI-Public: (01)00613994743831
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2017

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 Model Number: MMT-723KNS
• Device Catalogue Number: MMT-723KNS
• Device Lot Number: A000170201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2017
• Initial Date Received by Manufacturer: 06/08/2017
• Supplement Date Received by Manufacturer: 10/30/2017
• Initial Report FDA Received Date: 07/03/2017
• Supplement Report FDA Received Date: 11/08/2017
• 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: 10 YR
• Patient Weight: 71