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

Model Number	MMT-522NAP
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	02/06/2018
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.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 they had high blood glucose.The customer's blood glucose was 418 mg/dl and after correction it went down to 275 mg/dl.At 11:36 blood glucose was 220 mg/dl and after carb intake at 1:35 it was 301 mg/dl and current blood glucose is 307 mg/dl.The customer declined troubleshooting on insulin pump.The customer treated high blood glucose with manual injection.The customer was neither hospitalized nor admitted for high blood glucose.Based on customer report customer does not allege pump was under delivering and drive support cap was normal.It was also reported that the there was scratches on the insulin pump screen.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
The insulin pump passed the displacement, rewind, basic occlusion, occlusion, prime and excessive no delivery tests.The insulin pump had cracked battery tube threads, cracked reservoir tube lip and minor scratched display window.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522NAP
• 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: 7287497
• Report Number: 3004209178-2018-52356
• Device Sequence Number: 2379252
• Product Code: OYC
• UDI-Device Identifier: 00613994622662
• UDI-Public: (01)00613994622662
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 06/22/2018

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-522NAP
• Device Catalogue Number: MMT-522NAP
• Device Lot Number: B1522NAPJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2018
• Initial Date Received by Manufacturer: 02/09/2018
• Supplement Date Received by Manufacturer: 05/25/2018
• Initial Report FDA Received Date: 02/21/2018
• Supplement Report FDA Received Date: 06/22/2018
• 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: Other
• Patient Age: 88 YR
• Patient Weight: 147