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

Model Number	MMT-522LNAL
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/03/2019
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.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's wife reported via phone call that the insulin pump had an unexpected restart error alarm and the button error.Customer¿s blood glucose value was unknown.Customer was not able to clear the alarm and not able to rewind the insulin pump.Customer stated that the time was advancing and insulin pump had frozen display.Customer was advised to discontinue the use of the insulin pump and refer the backup plan as per health care professional instruction.The device will be returned for the analysis.
Additional Manufacturer Narrative
Insulin pump received with no (act, up and escape) button response due to corroded keypad traces.No button error alarm during testing noted.Unable to perform all functional testing including the displacement, operating currents, a21 alarm, rewind, basic occlusion, occlusion, prime a33 and excessive no delivery test due to buttons not responding.
Event or Problem Description
It was reported via phone call that the weight has been changed to (b)(6).

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522LNAL
• 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: 9173922
• Report Number: 2032227-2019-100980
• Device Sequence Number: 2693032
• Product Code: OYC
• UDI-Device Identifier: 00613994407719
• UDI-Public: (01)00613994407719
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2019

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-522LNAL
• Device Catalogue Number: MMT-522LNAL
• Device Lot Number: A000113848
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2019
• Initial Date Received by Manufacturer: 10/03/2019
• Supplement Date Received by Manufacturer: 10/24/2019
• Initial Report FDA Received Date: 10/10/2019
• Supplement Report FDA Received Date: 10/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 88