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

Model Number	MMT-751PNAP
Medical Device Problem Codes	Detachment of Device or Device Component (2907); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Hyperglycemia (1905); Vomiting (2144)
Date of Event	05/13/2019
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
The customer reported via phone call that her daughter was hospitalized and due to infection and high blood glucose was 1200 mg/dl on (b)(6) 2019.The customer¿s blood glucose level was 1200 mg/dl and 320 mg/dl at the time of incident.The customer was treated with manual, intravenous and insulin drip.The customer does not allege pump was under delivering.It was reported that the drive support cap was sticking out.Customer has been using insulin pump system within 48 hours of reported high blood glucose event.The customer was advised that the insulin pump needs to be replaced.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
(b)(4).Device passed the functional test, including the displacement test, rewind, basic occlusion test, occlusion test, prime test, excessive no delivery test and dat test at 0.08770 inches.The stop (idle) current and run current measurement tests are within specification.Device also passed self test, off no power alarm test and unexpected restart error test.Device uploaded properly using carelink.Drive support disk was inspected and no anomaly was noted.Device had minor scratched display window, scratched case, scratched reservoir tube window and cracked reservoir tube lip.

• Brand Name: 530G INSULIN PUMP MMT-751PNAP
• 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: 8631174
• Report Number: 2032227-2019-05527
• Device Sequence Number: 1655176
• Product Code: OZO
• UDI-Device Identifier: 00643169507340
• UDI-Public: (01)00643169507340
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 06/19/2019

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-751PNAP
• Device Catalogue Number: MMT-751PNAP
• Device Lot Number: A3751PNAPJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2019
• Initial Date Received by Manufacturer: 05/18/2019
• Supplement Date Received by Manufacturer: 06/12/2019
• Initial Report FDA Received Date: 05/22/2019
• Supplement Report FDA Received Date: 06/19/2019
• 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-UNK-RSR, UNOMED INFSET
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 61 YR
• Patient Weight: 94