MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-751NAS; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-751NAS

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Hypoglycemia (1912); Seizures (2063)

Event Date 08/27/2018

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.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 Description

Customer's grandparent reported via phone call that the customer got hospitalized due to low blood glucose on (b)(6) 2018 with blood glucose of 10 mg/dl at the time of the incident.The customer was at 191 mg/dl at the time of the call.The customer was given honey and glucagon shots to treat.The customer experienced symptoms such as seizures.The customer was wearing the insulin pump during the incident.The pump had physical damage and the caller believes the pump was over delivering.Troubleshooting was not completed.The insulin pump will be returned for analysis.

Manufacturer Narrative

Unit received with operating currents within specification.Unit passed self test, unexpected restart error test, displacement test and basic occlusion test.Unable to prime unit during prime test due to faulty force sensor resistor.Unable to perform occlusion test, delivery accuracy test and excessive no delivery test due to prime anomaly.Unit received with cracked case at display window corners, display window, reservoir tube lip, reservoir tube window, reservoir tube window corners and battery tube threads.Unit received with minor scratched display window and case.Unit received with stained end cap sticker and back address serial number label.Unit received with broken belt clip slot and stripped battery cap coin slot.

• Brand Name: 530G INSULIN PUMP MMT-751NAS
• 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: 7875975
• MDR Text Key: 120238989
• Report Number: 2032227-2018-28099
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169404342
• UDI-Public: (01)00643169404342
• 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,Followup
• Report Date: 10/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-751NAS
• Device Catalogue Number: MMT-751NAS
• Device Lot Number: A3751NASJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2014
• 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
• Patient Outcome(s): Other
• Patient Age: 19 YR
• Patient Weight: 157