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

Model Number	MMT-551NAB
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	07/17/2019
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 level of 418 mg/dl.Customer stated that she was about to eat her lunch but then noticed a message in the insulin pump that says no delivery.Customer was advised that the position of motor may have shifted.Customer was advised to disconnect at the quick release.Customer was assisted in performing a 5.0 unit fixed prime.Customer stated the insulin exited.Customer was able to remove set at this time to test site portion of infusion set.Customer was advised to remove the set and examine the cannula.Customer stated the cannula was bent.Customer reported that they already had her manual injections and they just bolus while they had successfully cleared the alarm.Customer declined to troubleshoot for high blood glucose.Insulin pump will not be returned for analysis.

• Brand Name: 530G INSULIN PUMP MMT-551NAB
• 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: 8853754
• Report Number: 2032227-2019-39934
• Device Sequence Number: 19339978
• Product Code: OZO
• UDI-Device Identifier: 00643169736016
• UDI-Public: (01)00643169736016
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-551NAB
• Device Catalogue Number: MMT-551NAB
• Device Lot Number: A6551NABJ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2019
• Initial Report FDA Received Date: 08/02/2019
• 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 INF SET
• Outcome Attributed to Adverse Event: Other
• Patient Age: 56 YR
• Patient Weight: 109