MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. KIT MMT-1754K PUMP 630G CAN BK MM; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-1754K

Device Problems Material Integrity Problem (2978); No Apparent Adverse Event (3189)

Patient Problems Headache (1880); Hyperglycemia (1905); Low Blood Pressure/ Hypotension (1914)

Event Date 08/19/2019

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

Event Description

It was reported that customer experienced high blood glucose level.The customer¿s blood glucose level was 33.3 mmol/l at the time of incident.Customer stated that they were in hospital due to low blood pressure.Customer also stated that the insulin pump was not working properly.The customer experienced symptoms such as headache.Customer was using insulin pump system within 48 hours of reported event.The customer was treated with bolus.Customer did not alleging insulin pump under delivering.Customer was advised to change the infusion set, reservoir and insulin and to treat per healthcare professional's instructions.Customer reported that the bolus wizard was programmed accurately.Customer performed self test and it was passed.Customer also mentioned that the battery cap contact was damaged.The device will not be returned for analysis.

Manufacturer Narrative

2032227-060322-002-c.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.

• Brand Name: KIT MMT-1754K PUMP 630G CAN BK MM
• 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: 8948673
• MDR Text Key: 156086348
• Report Number: 2032227-2019-55427
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169976344
• UDI-Public: (01)00643169976344
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 06/10/2022

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-1754K
• Device Catalogue Number: MMT-1754K
• Device Lot Number: HG1T8U6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/22/2019
• Initial Date FDA Received: 08/30/2019
• Supplement Dates Manufacturer Received: 06/03/2022
• Supplement Dates FDA Received: 06/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: 2032227-060322-002-C
• Patient Sequence Number: 1
• Treatment: FRN-UNK-RSVRUNOMED SET; FRN-UNK-RSVRUNOMED SET
• Patient Outcome(s): Other