MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522LNAH; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-522LNAH
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/03/2017
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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.
Event or Problem Description
Customer's father reported via phone call keypad anomaly and battery out limit alarm.Troubleshooting for the malfunctions was not performed.Customer declined to return the device.
Additional Manufacturer Narrative
The information provided with the initial report iwas incorrect.However, we have received new information which has been updated on this report to reflect the correct information.
Event or Problem Description
The customer reported experiencing a motor error alarm and unexpected restart error alarm on the insulin pump.Troubleshooting was not performed and the customer's blood glucose was not provided.The insulin pump will not be returned for analysis.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522LNAH
• 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: 6610057
• Report Number: 2032227-2017-20646
• Device Sequence Number: 339598
• Product Code: OYC
• UDI-Device Identifier: 00613994597212
• UDI-Public: (01)00613994597212
• 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): 06/27/2017

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-522LNAH
• Device Catalogue Number: MMT-522LNAH
• Device Lot Number: A000139228
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/03/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/02/2017
• Supplement Report FDA Received Date: 06/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 16 YR
• Patient Weight: 68