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

Model Number	MMT-522LNAP
Medical Device Problem Codes	No Apparent Adverse Event (3189); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	12/17/2018
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
Customer reported via phone call that they experienced high blood glucose.The customer blood glucose level was 463 mg/dl at the time of incident.Customer states the reservoir was able to lock in place.Customer states she did not have any alarms but the pump was making noises on the pump.The customer did not provide details regarding symptoms and treatment of high blood glucose.Customer declined to troubleshooting for their high blood glucose levels.The insulin pump will not be returned for analysis.
Additional Manufacturer Narrative
Insulin pump passed the displacement test, rewind, basic occlusion, occlusion, prime and excessive no delivery test.Insulin pump received with cracked reservoir tube lip.

• 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 MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• MDR Report Key: 8183610
• Report Number: 2032227-2018-77566
• Device Sequence Number: 1300298
• Product Code: OYC
• UDI-Device Identifier: 00613994407702
• UDI-Public: (01)00613994407702
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2019

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: A000114033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2019
• Initial Date Received by Manufacturer: 12/17/2018
• Supplement Date Received by Manufacturer: 04/03/2019
• Initial Report FDA Received Date: 12/20/2018
• Supplement Report FDA Received Date: 04/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FRN-UNK-RSVR, UNOMED SET
• Outcome Attributed to Adverse Event: Other
• Patient Age: 54 YR
• Patient Weight: 63