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 Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Hyperglycemia (1905); Hypoglycemia (1912)
Date of Event	07/25/2020
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.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 they experienced hyperglycemia as well as hypoglycemia.The customer's blood glucose level ranged from 42 mg/dl to 400 mg/dl.The insulin pump was cracked at the battery compartment and reservoir compartment.The customer declined troubleshooting for high as well as low blood glucose level.The insulin pump will be returned for analysis.Frn-unk-rsvr, unomed inf set.
Additional Manufacturer Narrative
Device passed the functional test, including the displacement test, rewind, basic occlusion test, occlusion test, prime/a33 test, excessive no delivery test and delivery accuracy test.No over delivery anomaly or under delivery anomaly noted.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 battery tube threads, cracked case at reservoir tube window corner and cracked reservoir tube lip.The test p-cap and reservoir does lock in place in the reservoir compartment.(b)(4).

• 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: 10348691
• Report Number: 2032227-2020-155499
• Device Sequence Number: 2485543
• Product Code: OZO
• UDI-Device Identifier: 00643169507708
• UDI-Public: (01)00643169507708
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 09/20/2020

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-551LNAH
• Device Catalogue Number: MMT-551LNAH
• Device Lot Number: A4551LNAHJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2020
• Initial Date Received by Manufacturer: 07/27/2020
• Supplement Date Received by Manufacturer: 09/18/2020
• Initial Report FDA Received Date: 07/31/2020
• Supplement Report FDA Received Date: 09/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Weight: 68