MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523LNAH; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-523LNAH
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	05/13/2017
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 reported via phone call compromised force sensor system alarm on the insulin pump.Customer¿s blood glucose level was 346 mg/dl.Troubleshooting for the prime rewind was performed.Customer advised during the manual prime process they received the alarm.Customer was advised to discontinue use of the device and revert to a backup plan.Customer was advised that the device would be replaced and agreed to return the product for analysis.
Additional Manufacturer Narrative
The insulin pump passed self test and unexpected restart error test.The insulin pump passed all operating currents tested with in the spec range and passed off no power test.Unable to confirm compromised force sensor alarm and unable to perform displacement test, rewind test, basic occlusion test, prime test, excessive no delivery test and occlusion test due to end cap broken off.The insulin pump received with cracked battery tube thread, cracked reservoir tube lip, cracked reservoir tube, cracked reservoir tube window, cracked case near display window corners, cracked on display window, missing end cap sticker and minor scratches on display window noted.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523LNAH
• 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: 6632307
• Report Number: 2032227-2017-20926
• Device Sequence Number: 16297068
• Product Code: OYC
• UDI-Device Identifier: 00613994918741
• UDI-Public: (01)00613994918741
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 10/19/2017

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-523LNAH
• Device Catalogue Number: MMT-523LNAH
• Device Lot Number: A000204284
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2017
• Initial Date Received by Manufacturer: 05/13/2017
• Supplement Date Received by Manufacturer: 10/16/2017
• Initial Report FDA Received Date: 06/09/2017
• Supplement Report FDA Received Date: 10/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 13 YR
• Patient Weight: 95