MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522LNAP; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-522LNAP
Health Effect - Clinical Codes	Dyspnea (1816); Hyperglycemia (1905); Nausea (1970)
Date of Event	04/14/2018
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 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
The customer was reported via phone call that, the customer was hospitalized on (b)(6) 2018 due to dehydration with high blood glucose.Customer¿s blood glucose at time of incident was 240 mg/dl and current blood glucose was 108 mg/dl.Customer reported the following symptoms related to their high blood glucose were usually difficulty breathing and nausea.Customer treated high blood glucose with the insulin pump.Customer went to the emergency room as he was dehydrated because heart rate had gone up high.Thought she was dehydrated and concerned with her heart was 143 over 76.Blood glucose value when admitted to hospital was 193 mg/dl.When admitted and after taking insulin 2 hours later it was 140 mg/dl.Customer was wearing the pump at time of hospitalization.Based on customer report customer does not allege pump was under delivering.The drive support cap appears normal.Customer states that she wants the pump to alarm her when the reservoir is low and to alarm so she can hear it.After reviewing the pump setting her audio is set to beep long and her low res settings are set to alarm at 20 units.Customer noticed that the pump was not alarming when insulin was low and went to get new blood glucose tester.The device is not expected to be returned for analysis.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522LNAP
• Common Device Name: PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• MDR Report Key: 7572540
• Report Number: 3004209178-2018-77797
• Device Sequence Number: 1698066
• Product Code: OYC
• UDI-Device Identifier: 00613994407702
• UDI-Public: (01)00613994407702
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 08/08/2018

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-522LNAP
• Device Catalogue Number: MMT-522LNAP
• Device Lot Number: A1522LNAPJ
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/14/2018
• Supplement Date Received by Manufacturer: 05/14/2018
• Initial Report FDA Received Date: 06/06/2018
• Supplement Report FDA Received Date: 08/08/2018
• 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: Hospitalization
• Patient Age: 52 YR
• Patient Weight: 113