MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-551LNAB; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number	MMT-551LNAB
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	02/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Insulin pump received with intermittent button response due to flattened (up and act ) button dome switch (no crease) and partial unlocked j2/lcd keypad connector noted during visual inspect.Unable to perform all functional testing including the displacement, operating currents, unexpected restart error test, rewind, basic occlusion, occlusion, prime, compromised forced sensor system and excessive no delivery test or verify lost sensor alarm due to buttons not responding.
Event or Problem Description
The customer¿s mother reported via phone call that the sensor had calibration error.The customer¿s blood glucose level was 390 mg/dl, and other relevant blood glucose level was 193 mg/dl.The customer also stated that they put new sensor and they got continuous sensor error.The customer passed the test plug procedure.Customer was using blue test plug.Customer stated that the led blinked on and off when connected to the test plug.Customer stated that there was no damage to the connection bridge or pins and sensor feature was on.Customer was assisted with troubleshooting for sensor error.The device will not be returned for analysis.

• Brand Name: 530G INSULIN PUMP MMT-551LNAB
• Common Device Name: ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• MDR Report Key: 9264832
• Report Number: 2032227-2019-111851
• Device Sequence Number: 19394057
• Product Code: OZO
• UDI-Device Identifier: 00643169932999
• UDI-Public: (01)00643169932999
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/31/2019

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-551LNAB
• Device Catalogue Number: MMT-551LNAB
• Device Lot Number: A5551LNABJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2019
• Initial Report FDA Received Date: 10/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 6 YR
• Patient Weight: 42