MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SENSOR MMT-7040C1 GUARDIAN4 5PK OUS 1; SENSOR, GLUCOSE, INVASIVE

Model Number MMT-7040C1

Device Problems Unexpected Therapeutic Results (1631); Calibration Problem (2890); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/26/2022

Event Type  malfunction  

Event Description

Information received by medtronic the user reported inaccurate sensor readings that triggered a threshold suspend.The customer¿s blood glucose was7.8 mmol/l and sensor glucose was 3.7 mmol/l at the time of the event, the difference is outside the acceptable range.Suspend on low limit in sensor settings was at 3.8 mmol/l.Customer received calibration not accepted alert.No harm requiring medical intervention was reported.The sensor will not be returned for analysis.

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.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: SENSOR MMT-7040C1 GUARDIAN4 5PK OUS 1
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386; * 00777-3869
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386; * 00777-3869
• Manufacturer Contact: tricha miles ; ceiba norte ind. park #50 road; juncos 00777--386 ; * 00777-3869 ; 7635140379
• MDR Report Key: 15238370
• MDR Text Key: 305172028
• Report Number: 2032227-2022-311262
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 000020763000413396
• UDI-Public: (01)000020763000413396(17)230404(10)HG65VKS
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/04/2023
• Device Model Number: MMT-7040C1
• Device Catalogue Number: MMT-7040C1
• Device Lot Number: HG65VKS
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/26/2022
• Date Device Manufactured: 04/04/2022
• 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