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

Model Number	MMT-551LNAP
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	05/08/2020
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 they were in the emergency room on (b)(6) 2020 due to low blood glucose level with a blood glucose level of 37 mg/dl and 47 mg/dl.The customer's blood glucose level was 22 mg/dl at the time of the incident.The customer also reported stomach related issues.The customer was treated with carbohydrates, crackers and apple juices at the emergency room.The drive support cap appeared normal.The insulin pump will not be returned for analysis.
Additional Manufacturer Narrative
The information provided that the event date with the initial report was incorrect.The correct information has been included with this report.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
The customer reported via phone call that they were in the emergency room on (b)(6) 2020 due to low blood glucose level with a blood glucose levels of 37 mg/dl and 47 mg/dl.The customer had been experiencing low blood glucose for two weeks and treated with glucose tablets.The customer also reported stomach related issues.The customer was treated with carbohydrates, crackers and apple juices at the emergency room.Troubleshooting was performed and the drive support cap appeared normal and the customer did not believe that the insulin pump was over delivering.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 or a33 test, excessive no delivery test and delivery accuracy test at 0.0871 inches.The stop (idle) 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 carelink.Device had cracked case at display window corner, cracked battery tube threads, cracked case at the reservoir tube window corner, cracked reservoir tube window, cracked reservoir tube lip and a missing end cap sticker.The test p-cap and reservoir does lock in place in the reservoir compartment.(b)(4).
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Customer has been experiencing low blood glucose values from (b)(6) 2020 to (b)(6) 2020 ranging from 22 mg/dl to 61 mg/dl.The device was returned for analysis.

• Brand Name: 530G INSULIN PUMP MMT-551LNAP
• 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: 10081475
• Report Number: 2032227-2020-121068
• Device Sequence Number: 3358140
• Product Code: OZO
• UDI-Device Identifier: 00643169507722
• UDI-Public: (01)00643169507722
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 12/29/2020

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-551LNAP
• Device Catalogue Number: MMT-551LNAP
• Device Lot Number: A4551LNAPJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2020
• Initial Date Received by Manufacturer: 05/18/2020
• Supplement Date Received by Manufacturer: 05/26/2020; 12/16/2020; 12/28/2020
• Initial Report FDA Received Date: 05/22/2020
• Supplement Report FDA Received Date: 05/28/2020; 12/17/2020; 12/29/2020
• 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-MMT-332-RSVR, UNOMED SET
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 49 YR
• Patient Weight: 54