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

Model Number MMT-551NAH

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

Patient Problems Hypoglycemia (1912); Seizures (2063); Coma (2417)

Event Date 11/11/2017

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

Customer called and reported that they got hospitalized due to low blood glucose on (b)(6) 2017 with blood glucose of 30 mg/dl at the time of the incident.The customer did not mention how they were treated.The customer experienced symptoms such as seizures, vomiting, aspiration, a mini stroke, and a coma.The customer was wearing the insulin pump during the incident.The customer reported sensor glucose versus blood glucose leading to their low.Troubleshooting was not completed as the customer no longer uses the pump.The insulin pump will not be returned for analysis.

• Brand Name: 530G INSULIN PUMP MMT-551NAH
• 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: 8988150
• MDR Text Key: 157300159
• Report Number: 2032227-2019-60442
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169503632
• UDI-Public: (01)00643169503632
• 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: 09/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-551NAH
• Device Catalogue Number: MMT-551NAH
• Device Lot Number: A4551NAHJ
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/30/2019
• Date Device Manufactured: 01/21/2016
• 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: OZO-MMT-7008FRN-MMT-326UNOMED SET
• Patient Outcome(s): Hospitalization
• Patient Age: 53 YR