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

Model Number	MMT-551LNAH
Medical Device Problem Codes	Device Difficult to Program or Calibrate (1496); Obstruction of Flow (2423); Material Integrity Problem (2978); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.
Event or Problem Description
The customer reported via phone call that their insulin pump act button did not always respond.The customer¿s blood glucose was unknown at the time of incident.The customer reported that the insulin pump had cracks in the casing, battery cap both ends and reservoir cracked and no delivery resulting in a site change.The insulin pump will not be returned for analysis.
Additional Manufacturer Narrative
All buttons functioning properly.No damage/unlocked lcd keypad connector during visual inspection noted.Device passed rewind test, basic occlusion test, occlusion test, prime test, excessive no delivery test and displacement test.No unexpected no delivery alarm noted during testing.Unit had stripped battery cap coin slot (p), broken battery tube threats, cracked reservoir tube lip.

• Brand Name: 530G INSULIN PUMP MMT-551LNAH
• 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: 8649147
• Report Number: 2032227-2019-08622
• Device Sequence Number: 2340490
• Product Code: OZO
• UDI-Device Identifier: 00643169933002
• UDI-Public: (01)00643169933002
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 03/05/2020

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-551LNAH
• Device Catalogue Number: MMT-551LNAH
• Device Lot Number: A5551LNAHJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2019
• Initial Date Received by Manufacturer: 05/24/2019
• Supplement Date Received by Manufacturer: 03/05/2020
• Initial Report FDA Received Date: 05/29/2019
• Supplement Report FDA Received Date: 03/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 180