MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-751RNAS; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-751RNAS
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	05/11/2017
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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.
Event or Problem Description
It was reported via phone call that the customer was hospitalized with diabetic ketoacidosis and a heart attack.The customer's blood glucose was over 1000 mg/dl at the time of the event.The caller reported stents were put in the customer's body.The caller reported the customer was hospitalized on (b)(6) 2017.The caller also reported the customer experienced renal failure and a pneumonia leading to the hospitalization.The customer was wearing the insulin pump at the time of event.The customer stated they have been treating their blood glucose with manual injections.Troubleshooting was not performed on the insulin pump.The insulin pump will not be returned for analysis.
Additional Manufacturer Narrative
Device passed the functional test, including the displacement test, rewind, basic occlusion test, occlusion test, prime test, excessive no delivery test and delivery accuracy test.The stop current and run current measurement tests are within specification.Device also passed self test, off no power alarm test and a21 error test.Device uploaded properly using care link.Device had a small crack on the display window, cracked reservoir tube lip and a missing end cap sticker.(b)(4).

• Brand Name: 530G INSULIN PUMP MMT-751RNAS
• Common Device Name: PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• MDR Report Key: 6618595
• Report Number: 3004209178-2017-53132
• Device Sequence Number: 13638110
• Product Code: OZO
• UDI-Device Identifier: 00643169508002
• UDI-Public: (01)00643169508002
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2019

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-751RNAS
• Device Catalogue Number: MMT-751RNAS
• Device Lot Number: A3751RNASJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2017
• Initial Date Received by Manufacturer: 05/19/2017
• Supplement Date Received by Manufacturer: 06/24/2019
• Initial Report FDA Received Date: 06/07/2017
• Supplement Report FDA Received Date: 07/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 73 YR
• Patient Weight: 180