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

Model Number	MMT-722RNAS
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	09/22/2017
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 their insulin pump had unexpected restart.The customer¿s blood glucose level was 274 mg/dl.Troubleshooting was performed for unexpected restart and receiving another unexpected restart alarm after a battery change.Advised that the pump will need to be replaced.The customer was also advised they may continue to wear pump until replacement arrives.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Insulin pump passed displacement test.Unit was received with unexpected restart error alarm during testing due to broken solder joint connector on interface board.Unit was received with missing end cap sticker, cracked case at display window corner, minor scratched lcd window, cracked battery tube threads, cracked belt clip slot at battery tube threads area and cracked reservoir tube lip.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722RNAS
• 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: 6912894
• Report Number: 2032227-2017-55493
• Device Sequence Number: 482703
• Product Code: OYC
• UDI-Device Identifier: 00613994409157
• UDI-Public: (01)00613994409157
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 02/05/2018

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-722RNAS
• Device Catalogue Number: MMT-722RNAS
• Device Lot Number: A000114517
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2017
• Initial Date Received by Manufacturer: 09/27/2017
• Supplement Date Received by Manufacturer: 01/23/2018
• Initial Report FDA Received Date: 10/03/2017
• Supplement Report FDA Received Date: 02/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 180