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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	04/10/2019
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.
Event or Problem Description
Customer reported via phone call that they experienced high blood glucose.The customer blood glucose level was 506 mg/dl at the time of incident and the current blood glucose of the patient is unknown.Customer also states that cracked on the reservoir compartment.Customer states reservoir unable to lock in place.Customer treated with insulin pump and manual injection.Troubleshooting was performed.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Device passed the displacement, rewind, basic occlusion, occlusion, prime and excessive no delivery test.No device deficiency anomaly noted during test.Device received with broken reservoir tube lip.

• 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: 8526266
• Report Number: 3004209178-2019-83784
• Device Sequence Number: 1928710
• Product Code: OZO
• UDI-Device Identifier: 00643169933002
• UDI-Public: (01)00643169933002
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 05/07/2019

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-551LNAH
• Device Catalogue Number: MMT-551LNAH
• Device Lot Number: A5551LNAHJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2019
• Initial Date Received by Manufacturer: 04/10/2019
• Supplement Date Received by Manufacturer: 05/04/2019
• Initial Report FDA Received Date: 04/18/2019
• Supplement Report FDA Received Date: 05/08/2019
• 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 INF SET.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 70 YR
• Patient Weight: 65