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

Model Number MMT-551LNAB

Device Problems Fluid/Blood Leak (1250); Improper or Incorrect Procedure or Method (2017); Inaccurate Delivery (2339); Device Displays Incorrect Message (2591)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912)

Event Date 08/09/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Currently it is unknown whether or not the device may have caused or contributed to the event.The device has been returned, but not yet evaluated.Further information will follow once the analysis has been completed.No conclusion can be drawn at this time.

Event Description

Customer¿s parent reported via phone call low blood glucose levels, high blood glucose levels and hospitalization.Customer blood glucose level went as low as 50 mg/dl and as high as 380 mg/dl.Customer experienced nausea, dehydration, pain in limbs, headache and they treated their high blood glucose via bolus delivery.Customer treated their low blood glucose levels via orange juice.Customer went to the hospital on (b)(6) 2017 at 12:00 pm.Customer current blood glucose level was 324 mg/dl.Customer¿s blood glucose went severely low because they accidentally delivered a bolus when they did not need it.Troubleshooting for compromised force sensor system was performed.Customer advised during the manual prime process insulin squirted out.Customer advised the drive support cap was normal.Customer advised during the seating of the force the sensor did not detect the reservoir.Customer was advised to discontinue use of the device and revert to a backup plan.Customer was advised that the device would be replaced and agreed to return the product for analysis.

Manufacturer Narrative

Findings: unit passed the dat test.All operating currents are within specification.No unexpected low battery or off no power alarms noted.Unit passed functional test including displacement test, rewind, basic occlusion, occlusion, prime, and excessive no delivery alarm test.No compromised forced sensor alarms or prime anomaly noted during testing.Unit functioned properly.Unit received with intermittent button response during testing due to flattened dome switch on the act button.Lcd connector was inspected and no anomaly was noted.Unit received with minor scratched lcd window and cracked reservoir tube lip.A complete analysis and testing of the insulin pump showed that it was functioning properly and passed all functional testing.After testing it was concluded that the device operated within specifications.

• Brand Name: 530G INSULIN PUMP MMT-551LNAB
• 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
• MDR Report Key: 6835018
• MDR Text Key: 84254625
• Report Number: 2032227-2017-43222
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169507692
• UDI-Public: (01)00643169507692
• 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,other
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date: 11/21/2017

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
• Device Operator: Lay User/Patient
• Device Model Number: MMT-551LNAB
• Device Catalogue Number: MMT-551LNAB
• Device Lot Number: A4551LNABJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/10/2017
• Initial Date FDA Received: 08/31/2017
• Supplement Dates Manufacturer Received: 11/14/2017
• Supplement Dates FDA Received: 11/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization
• Patient Age: 10 YR
• Patient Weight: 80