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

Model Number	MMT-751NAP
Medical Device Problem Codes	Mechanical Problem (1384); Battery Problem (2885); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	08/03/2020
Type of Reportable Event	Serious Injury
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 the customer was hospitalized due to low blood glucose level.Customer stated that the insulin pump was cracked in reservoir window.Customer stated that the insulin pump was grinding during rewind.The insulin pump will not be returned for analysis.
Additional Manufacturer Narrative
The information that provided with the initial report was incorrect.The correct information has been included with this report.(b)(4).
Event or Problem Description
It was stated that the customer was also going through batteries more quickly.Customer said the low blood glucose and hospitalization was her fault.
Additional Manufacturer Narrative
Device monitored for several days.Device received with all operating currents within specification and passed displacement test and rewind test.No unexpected low battery alarm anomalies noted.No unexpected rewind anomalies noted.Device received with cracked case from reservoir tube window corners, cracked reservoir tube window and cracked reservoir tube lip.The test infusion set and reservoir does lock into place.(b)(4).

• Brand Name: 530G INSULIN PUMP MMT-751NAP
• 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: 10389254
• Report Number: 2032227-2020-160593
• Device Sequence Number: 2898319
• Product Code: OZO
• UDI-Device Identifier: 00643169503700
• UDI-Public: (01)00643169503700
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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,Followup
• Report Date (Section B): 11/11/2020

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-751NAP
• Device Catalogue Number: MMT-751NAP
• Device Lot Number: A4751NAPJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2020
• Initial Date Received by Manufacturer: 08/03/2020
• Supplement Date Received by Manufacturer: 09/22/2020; 11/11/2020
• Initial Report FDA Received Date: 08/11/2020
• Supplement Report FDA Received Date: 09/23/2020; 11/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FRN-UNK-RSVR,UNOMED SET
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 57 YR