MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SENSOR ENLITE MMT-7008A; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-7008A

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem Hyperglycemia (1905)

Event Date 05/25/2018

Event Type  Injury  

Manufacturer Narrative

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

Complaints text 05/27/2018.Erp_rfc_user related svn (b)(4).Complaints text 05/27/2018.Erp_rfc_user related svn (b)(4).Complaints text 05/27/2018.Erp_rfc_user related svn (b)(4).Complaints text 05/27/2018.(b)(6).Initial notes: i was having issues with the sensor.Cust said that she got a cal not accepted message then a change sensor inquired what led up to the complaint.Customer response: cust said she bg was high at the time customer's outcome pertaining to the complaint: rtn/rpl sensor and set.Additional notes: (b)(4).Cust treated with the pump.Did get s/n for pump.Caller also said she had an issue where the needle on the reservoir would not go all the way down.Ref: mmt-7008a, lot: hg2efq9 exp: 2018-09-17 ref: mmt-332a, lot: hg2gwss, exp 2021-04-21, cust declined t/s.Ship: mmt-7008b, mmt-332at, can le / return: mmt-7008a, mmt-332a.Reason for return: products not working.

Manufacturer Narrative

Inspected one opened and used sensor and performed continuity resistance test.Sensor passed per specification.Also, performed bicarbonate buffer test.Sensor passed per specifications with accurate readings.

• Brand Name: SENSOR ENLITE MMT-7008A
• 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: 7633291
• MDR Text Key: 112152445
• Report Number: 3004209178-2018-84743
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 20643169786725
• UDI-Public: (01)20643169786725(17)180917(10)HG2EFQ9
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 01/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/17/2018
• Device Model Number: MMT-7008A
• Device Catalogue Number: MMT-7008A
• Device Lot Number: HG2EFQ9
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2018
• Date Manufacturer Received: 01/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: MMT-332A; PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
• Patient Outcome(s): Other
• Patient Age: 58 YR