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 Codes	Insufficient Flow or Under Infusion (2182); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Abdominal Pain (1685); Dyspnea (1816); Hyperglycemia (1905); Nausea (1970); Vomiting (2144); Elevated ketones/Diabetic Ketoacidosis (2364)
Date of Event	03/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.(b)(4).
Event or Problem Description
The customer reported via phone call that they were hospitalized due to high blood glucose, diabetic keto acidosis on (b)(6) 2020 with blood glucose level was 767 mg/dl.Customer was experienced symptoms such as nausea, vomiting, abdominal pain, difficulty breathing.Customer had been using insulin pump system within 48 hours of reported high blood glucose event.The customer was treated with intravenous drip.Customer allege insulin pump was under delivering.Troubleshooting was performed.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
A test p-cap and reservoir locks into place inside the reservoir compartment properly.Device was received with the operating currents within specification.And passed the functional testing including self test, a21 error test, rewind, basic occlusion test, occlusion test, prime/a33 test, excessive no delivery test, displacement test, and the delivery accuracy test.No under delivery anomaly noted during testing.(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: 9932128
• Report Number: 3004209178-2020-95297
• Device Sequence Number: 666052
• Product Code: OZO
• UDI-Device Identifier: 00643169507715
• UDI-Public: (01)00643169507715
• 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
• Report Date (Section B): 04/22/2020

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-551LNAL
• Device Catalogue Number: MMT-551LNAL
• Device Lot Number: A4551LNALJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2020
• Initial Date Received by Manufacturer: 03/29/2020
• Supplement Date Received by Manufacturer: 04/14/2020
• Initial Report FDA Received Date: 04/07/2020
• Supplement Report FDA Received Date: 04/22/2020
• 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: UNOMED INF SET
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 67 YR
• Patient Weight: 160