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 Display/Image (1183); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	03/11/2019
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 the customer experienced hyperglycemia.The customer's blood glucose level was 570 mg/dl at the time of incident.The customer was assisted with troubleshooting.The customer was treated with manual injections for high blood glucose level.Customer stated that the insulin pump had died.The insulin pump will not be returned for analysis.
Additional Manufacturer Narrative
Device received with reservoir tube lip completely broken off noted.The test reservoir does not stay locked in place due to reservoir tube lip broken off.Unable to perform displacement test due to reservoir lip broken.Device passed displacement test, self test, off no power test and all operating currents tested within the specific range.No blank display noted.

• 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: 8459113
• Report Number: 2032227-2019-02645
• Device Sequence Number: 354787
• Product Code: OYC
• UDI-Device Identifier: 00613994407702
• UDI-Public: (01)00613994407702
• 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: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2020

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: 10/23/2019
• Initial Date Received by Manufacturer: 03/21/2019
• Supplement Date Received by Manufacturer: 03/27/2020
• Initial Report FDA Received Date: 03/28/2019
• Supplement Report FDA Received Date: 04/06/2020
• 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 INF SET
• Outcome Attributed to Adverse Event: Other
• Patient Age: 52 YR
• Patient Weight: 125