MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-751NAB; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number	MMT-751NAB
Medical Device Problem Codes	Device Difficult to Program or Calibrate (1496); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	04/01/2019
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
The customer reported via phone call that buttons of the insulin pump are hard to press.The customer's blood glucose level was more than 300 mg/dl and 280 mg/dl at time of incident.The customer also reported that the insulin was squirting out of the pump whenever she fills the cannula.Advised the insulin pump will need to be replaced and to discontinue use of the pump and revert to backup plan.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Insulin pump received with intermittent button response due to flattened (escape and act ) button dome switch (no crease) and partial unlocked 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 and excessive no delivery test due to buttons not responding.Pump received with cracked case display window corner.

• Brand Name: 530G INSULIN PUMP MMT-751NAB
• 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: 8581774
• Report Number: 3004209178-2019-93344
• Device Sequence Number: 1941615
• Product Code: OZO
• UDI-Device Identifier: 00643169736061
• UDI-Public: (01)00643169736061
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 06/10/2019

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-751NAB
• Device Catalogue Number: MMT-751NAB
• Device Lot Number: A6751NABJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2019
• Initial Date Received by Manufacturer: 05/01/2019
• Supplement Date Received by Manufacturer: 06/04/2019
• Initial Report FDA Received Date: 05/06/2019
• Supplement Report FDA Received Date: 06/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Weight: 82