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

Model Number	MMT-551LNAB
Medical Device Problem Codes	Device Alarm System (1012); No Display/Image (1183); Power Problem (3010)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	07/22/2019
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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.
Event or Problem Description
The customer reported via phone call that they experienced high blood glucose levels.The customer¿s blood glucose level was over 500 mg/dl and 195 mg/dl.The customer reported that they treated high blood glucose level with the manual injections.The customer did not mention any symptom related to high blood glucose level.Customer stated that she changed the battery prior to her having the high blood glucose levels, customer stated she did not get any alarms either.Customer checked the alarm history and found low battery only.Customer stated she had to mess with it for like an hour before she could get the insulin pump to respond.Customer declined troubleshooting for high blood glucose event and blank display.The insulin pump will not be returned for analysis.

• Brand Name: 530G INSULIN PUMP MMT-551LNAB
• 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: 8849531
• Report Number: 2032227-2019-39377
• Device Sequence Number: 259792
• Product Code: OZO
• UDI-Device Identifier: 00643169932999
• UDI-Public: (01)00643169932999
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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
• Report Date (Section B): 08/01/2019

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-551LNAB
• Device Catalogue Number: MMT-551LNAB
• Device Lot Number: A5551LNABJ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2019
• Initial Report FDA Received Date: 08/01/2019
• 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-RSVR,UNOMED SET
• Outcome Attributed to Adverse Event: Other
• Patient Age: 61 YR
• Patient Weight: 160