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

Model Number MMT-7008A

Device Problem Material Twisted/Bent (2981)

Patient Problem Blood Loss (2597)

Event Date 01/26/2020

Event Type  malfunction  

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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.(b)(4).

Event Description

The customer reported via phone call that the customer was hospitalized due to blood loss, on unknown date.The customer¿s blood glucose value was 97 mg/dl.Customer stated that the site was not actively bleeding.Customer stated that the sensor cannula was bent.The device will not be returned for analysis.

Manufacturer Narrative

The initial report had inappropriate reportability decision.The information has been given.

Event Description

Initial report had incorrect reportability decision and as per notes there was no reportable event that required medical intervention.

Manufacturer Narrative

Information has been corrected which was not correct in the initial report.The information has been provided in section b1 and b5 with this report.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Event Description

Medtronic received information that the customer had bent sensor cannula and bled at insertion site.The customer was not admitted to the hospital due to blood loss.

• 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 ; 8185464805
• MDR Report Key: 9657039
• MDR Text Key: 177363974
• Report Number: 3004209178-2020-62941
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 20643169786725
• UDI-Public: (01)20643169786725(17)200328(10)HG3RTTP
• 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,Followup
• Report Date: 04/15/2022

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 Expiration Date: 03/28/2020
• Device Model Number: MMT-7008A
• Device Catalogue Number: MMT-7008A
• Device Lot Number: HG3RTTP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/26/2020
• Initial Date FDA Received: 02/02/2020
• Supplement Dates Manufacturer Received: 02/03/2020; 04/15/2022
• Supplement Dates FDA Received: 02/05/2020; 04/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2019
• 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: FRN-UNK-RSVR,UNOMED INF SET; FRN-UNK-RSVR,UNOMED INF SET
• Patient Outcome(s): Hospitalization
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 232 KG