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

Model Number MMT-751NAB

Device Problems Excess Flow or Over-Infusion (1311); No Apparent Adverse Event (3189)

Patient Problems Hypoglycemia (1912); Seizures (2063)

Event Date 04/27/2020

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 reported via phone call that they were hospitalized on (b)(6) 2020 as a result of hypoglycemia.Customer¿s blood glucose level at the time of incident was 53 mg/dl and 82 mg/dl at the time of hospitalization.Customer had been using insulin pump system within 48 hours of reported low blood glucose event.Customer had been experiencing low blood glucose for about 3 weeks since (b)(6) 2020.Customer stated that while in ambulance they were treated with intravenous sugar and in hospital was treated with glucose tablets and food.Customer stated that insulin pump was over delivering.Customer stated they are unable to describe any possible damage to the drive support cap.The reservoir will not be returned for analysis while the insulin pump will be returned for analysis.

Manufacturer Narrative

Device passed the functional test, including the displacement test, rewind, basic occlusion test, occlusion test, prime/a33 test, excessive no delivery test and delivery accuracy test at 0.08750 inches.No over delivery anomaly or under delivery anomaly noted.The stop current and run current measurement tests are within specification.Device also passed self test, off no power alarm test and a21 error test.Device uploaded properly using care link.Drive support disk was inspected and no anomaly was noted.Device had cracked case at display window corner, scratched reservoir tube window, cracked reservoir tube lip and a missing end cap sticker.The test p-cap and reservoir does lock in place in the reservoir compartment.(b)(4).

• Brand Name: 530G INSULIN PUMP MMT-751NAB
• 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: 10031729
• MDR Text Key: 190109506
• Report Number: 2032227-2020-114500
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169404304
• UDI-Public: (01)00643169404304
• 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: 05/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-751NAB
• Device Catalogue Number: MMT-751NAB
• Device Lot Number: A2751NABJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2020
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2014
• 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
• Treatment: UNOMED INFSET
• Patient Outcome(s): Hospitalization
• Patient Age: 53 YR
• Patient Weight: 180