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

Model Number	MMT-551LNAL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	10/19/2019
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
It was reported via phone call by the customer's parent that the customer got hospitalized due to low blood glucose on (b)(6) 2019 with blood glucose of 30 mg/dl at the time of the incident.The caller did not mention how the customer was treated.The customer experienced symptoms such as being belligerent.The customer was wearing the insulin pump during the incident.Troubleshooting was not completed as the customer was unavailable at the time of the call.The insulin pump will 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 at 0.08740 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 minor scratched display window, broken battery tube threads and cracked reservoir tube lip.(b)(4).

• Brand Name: 530G INSULIN PUMP MMT-551LNAL
• 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: 9254250
• Report Number: 2032227-2019-110912
• Device Sequence Number: 3671870
• Product Code: OZO
• UDI-Device Identifier: 00643169933019
• UDI-Public: (01)00643169933019
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 11/14/2019

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-551LNAL
• Device Catalogue Number: MMT-551LNAL
• Device Lot Number: A5551LNALJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2019
• Initial Date Received by Manufacturer: 10/22/2019
• Supplement Date Received by Manufacturer: 11/13/2019
• Initial Report FDA Received Date: 10/30/2019
• Supplement Report FDA Received Date: 11/14/2019
• 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-326-RSVRUNOMED SET
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 12 YR