MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. KIT MMT-7745X IPRO2 SYSTEM CLINICAL; GLUCOSE OXIDASE, GLUCOSE

Model Number MMT-7745X

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hypoglycemia (1912)

Event Date 11/28/2019

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 is estimated that 13%¿20% of older people with dementia also have coexisting diabetes.Over the coming decades, this will pose a significant healthcare burden, especially in a worldwide expectation that by 2045, 629 million people with be living with diabetes and 125 million people will be living with dementia by 2050.Newer technologies, such as continuous glucose monitoring (cgm), have gained momentum in the management of diabetes, in particular in children and younger adults.This is now accompanied by a rapidly growing interest towards research studies of cgm in older people.A systematic review of studies using cgm in older people found that hypoglycaemic episodes were occurring in 28%¿65% of participants with most of those episodes (80%) being asymptomatic.Some participants spent up to 2 hours per day in the hypoglycaemic range.The review reported that older people found cgm use to be acceptable, with potential improvements in health-related well-being.This feasibility study aimed to estimate the important parameters for the sample size calculation for a full trial; no sample size calculation was undertaken at this stage.Researchers aimed to recruit up to 20 participants.This was a size that the research team considered to be pragmatic and sufficient as indicative quantitative data on which to base the sample size for a full trial.At commencement of this feasibility study, a cgm device (name omitted) was licensed for use in children and adults and available direct to consumers via the internet or from pharmacies.Eligible participants were 65 or older with type 1 or type 2 diabetes mellitus.They needed to be on glucose-lowering medication (not diet or metformin only), have an abbreviated mini-mental test (amt) score equal or less than 8 (out of 10) or already have a formal diagnosis of dementia.Use of the amt was mandated as a screening tool for memory problems in the hospital policy.In addition, a 2019 japanese study investigated the use of blinded cgm (medtronic ipro2) in older people in an outpatient setting in japan.Out of 326 participants, 7 used cgm.Asymptomatic hypoglycaemic episodes occurred in five out of the seven cgm users.It is potentially feasible for older people with diabetes and memory problems to operate a cgm device that requires users to conduct intermittent scans.However, the added benefit of real-time transmission cgm devices that do not require active scanning needs to be explored further in this group of patients.

Manufacturer Narrative

Supplemental report created for the initial mdr report that was submitted inappropriately as the device did not contribute to an adverse event.

• Brand Name: KIT MMT-7745X IPRO2 SYSTEM CLINICAL
• Type of Device: GLUCOSE OXIDASE, GLUCOSE
• 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: 9520224
• MDR Text Key: 173892089
• Report Number: 2032227-2019-138014
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-7745X
• Device Catalogue Number: MMT-7745X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/07/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other