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 Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Hyperglycemia (1905); Vomiting (2144); Elevated ketones/Diabetic Ketoacidosis (2364)
Date of Event	10/10/2019
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 they were hospitalize due to high blood glucose level with diabetic ketoacidosis on (b)(6) 2019.Customer¿s blood glucose level was 560 mg/dl, at the time of hospitalization.Customer had vomiting and positive ketones test.Customer was treat with insulin drip after admission.Customer declined to continue the troubleshooting for possible cause of high blood glucose level.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
The insulin pump was received with the operating currents within spec.And passed the functional testing including self test, a21 error test, rewind, basic occlusion test, occlusion test, prime test, excessive no delivery test, displacement test, and the delivery accuracy test at 0.08745 inches.The insulin pump was received with cracked reservoir tube lip, cracked battery tube threads, minor scratched lcd window, and scratched reservoir tube window.(b)(4).

• 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: 9196298
• Report Number: 2032227-2019-104629
• Device Sequence Number: 305492
• Product Code: OZO
• UDI-Device Identifier: 00643169933026
• UDI-Public: (01)00643169933026
• 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): 11/07/2019

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-551LNAP
• Device Catalogue Number: MMT-551LNAP
• Device Lot Number: A5551LNAPJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2019
• Initial Date Received by Manufacturer: 10/11/2019
• Supplement Date Received by Manufacturer: 11/05/2019
• Initial Report FDA Received Date: 10/16/2019
• Supplement Report FDA Received Date: 11/08/2019
• 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-RSVR, UNOMED SET
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 26 YR
• Patient Weight: 61