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

Model Number MMT-551NAB

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Hypoglycemia (1912); Pain (1994); Scarring (2061); Shock, Insulin (2264)

Event Date 09/10/2018

Event Type  Injury  

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 Description

The customer reported via phone call that they were hospitalized on (b)(6) 2017 for a blood glucose of 40 mg/dl.The customer believed that the infusion set caused an over-delivery.Customer has been using insulin pump system within 48 hours of the hospitalization.The patient treated with glucagon and food.Additionally, the customer's blood glucose dropped to less than 13 mg/dl.The blood glucose was 51 mg/dl at the time of the incident and current blood glucose was 315 mg/dl and other blood glucose values were 354 mg/dl.The customer stated that, 31 years ago she was at 13 mg/dl blood glucose, while she pregnant at time the customer had suffered from a convulsion, fell, and hit their head.The customer received a scar on her eyebrow and was gushing blood.Troubleshooting was not completed for the low blood glucose.The insulin pump was not returned for analysis.

• Brand Name: 530G INSULIN PUMP MMT-551NAB
• Type of Device: ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• Manufacturer Contact: gerwin de graaff ; ceiba norte ind. park #50 road; juncos 00777--386 ; 8185464805
• MDR Report Key: 7908854
• MDR Text Key: 121698859
• Report Number: 2032227-2018-33422
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169503625
• UDI-Public: (01)00643169503625
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/25/2018

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
• Device Operator: Lay User/Patient
• Device Model Number: MMT-551NAB
• Device Catalogue Number: MMT-551NAB
• Device Lot Number: A4551NABJ
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/11/2018
• Initial Date FDA Received: 09/26/2018
• Date Device Manufactured: 01/27/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: FRN RESERVOIRUNOMEDICAL INF. SET
• Patient Outcome(s): Hospitalization
• Patient Age: 59 YR
• Patient Weight: 181