MAUDE Adverse Event Report: TRIVIDIA HEALTH, INC. TRUEMETRIX; BLOOD GLUCOSE SYSTEM

Model Number TRUEMETRIX

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Death (1802)

Event Date 05/10/2017

Event Type  Death  

Manufacturer Narrative

(b)(4).Product not yet returned for evaluation.Most likely underlying root cause: user had an inaccurate reference: self: the person is using themselves as the reference or how they feel at the time they run the blood test.(b)(4).Manufacturer notes: trividia health internal review for customer (b)(6) history found: original complaint - error messages -history showed 2 meters issued to mrs.(b)(6).#1 true metrix s/n (b)(4) strip lot#mt1844 - initial call ran #(b)(4) #2 true metrix s/n (b)(4) strip lot#mt2256 - replacement ran #(b)(4)(replacement product sent on original ran# (b)(4)).On (b)(6) 2017: date complaint received: ran#(b)(4)- customer's husband ((b)(6)) called on behalf mrs.(b)(6) to say the customer was getting error messages when she performs her blood test.Technician was unable to verify the error message.The customer declined to perform any blood test during the call because "is very sick today".Note: customer complaint is for error messages, unable to describe errors.Information provided does not list any adverse event, medical attention or injury, therefore complaint was not reportable at the time.On (b)(6) 2017: replacement products sent: s/n# (b)(4) strip lot# mt2256.On (b)(6) 2017: follow- up call from trividia health made on, mrs.(b)(6) meter.Mr.(b)(6) (customer husband) stated "he does not like the product and that he will be purchasing another brand".No products sent back for investigation at this time.Manufacturer has no evidence based on the call back on (b)(6) 2017 that mrs.(b)(6) used the replacement product s/n (b)(4).On (b)(6) 2017: follow-up call from trividia health was made to mr.(b)(6) regarding his replacement meter and mr.(b)(6) informed customer care that wife had passed away (medwatch -mfr.Report #1000113657-2017-00982) on (b)(6) 2017: mr.(b)(6) contacted customer care manager.Mr.(b)(6) was asked directly about his wife's cause of death and he stated, "it was due to the "cancer medication which caused her heart and lungs to fail" - based on information provided, the complaint was not reportable at that time.It does not meet the definition of an mdr.On (b)(6) 2017: email notification from retailer.Manufacturer was contacted with new information about existing customer and complaint logged into heat system already.Patient claims true matrix inaccurate and contributed to adverse event - customer indicated that "readings are all over the place and he is blaming the meter as a cause for his wife's death and his diabetes-driven eye disease that he was just diagnosed with".Manufacturer to evaluate "new information" provided and review the potential incident report.On (b)(6) 2017 call back from trividia health to customer's husband based on the information provided by retailer, see for further details ran# (b)(4).Call back notes: per manufacturer process a follow up call to the customer was completed to get the 4 products back for investigation.Customer rep.Was able to make contact with mr.(b)(6) who stated that he was "asked by retailer not to send the products back to us".He stated he "will not be releasing the products back to us".There will be no products returned for investigation at this time.On (b)(6) 2017: compliance review based on retailer complaint information: "report reviewed for possible mdr regarding new information provided by the customer to retailer about his blood concerns.The outcome of this report will be determined according with the additional information provided.Based on customer new indication to distributor of meter "readings are all over the place" (erratic) and statement that he feels the "meter causing his wife death", the complaint is reportable - it does meet the definition of an mdr per 21 cfr 803.3." on (b)(6) 2017: qc investigation evaluation: customer did not return product.Retention test performed on (b)(6) 2017 on the same lot number used by the customer.Retention test results are acceptable per internal procedure.Reported defect not reproduced.Qc investigation protocol and test resulted in test strips worked as intended.Final manufacturer narrative: customer has a total of 4 meters, therefore manufacturer is reporting a total of 4 mdrs since customer could not identify the event to specific product.Three additional medwatch reports below: 1000113657-2017-00982, 1000113657-2017-00983, 1000113657-2017-00984.In addition, manufacturer consider that: customer complaints are inconsistent customer would not trouble shoot product customer is not cooperative with manufacturer repeat efforts.For instance: - will not return product for investigation - asked manufacturer to be removed from call back list.

Event Description

Information received via email on (b)(6) 2017 from retailer which reported a customer complaint for erratic results."patient claims": true metrix inaccurate and contributed to adverse event; readings are all over the place"; he is blaming the meter as a cause for his wife's death; pharmacist had no issues when customer was in-store when reviewing his electronic log, the meter seemed to be consistent with what he was expecting the majority of the time (150s - 170s for him) but would read inconsistently when reaching higher (or reportedly lower) values.For example, there was one recorded instance where the meter read his level as 230 and then when he re-tested, it recorded 280 1 minute later (zone a in parkes error grid).He reported other instances of similar variation in test results (most commonly at higher test results but also with a low test result for his wife) but we did not review those values other than his verbal report.He was most concerned about the inconsistency and varying insulin doses that would be then be given based on the test results plus any adverse events that would then result from the potentially erroneous meter result.

• Brand Name: TRUEMETRIX
• Type of Device: BLOOD GLUCOSE SYSTEM
• Manufacturer (Section D): TRIVIDIA HEALTH, INC.; 2400 nw 55th court; fort lauderdale FL 33309
• Manufacturer Contact: karen devincent ; 2400 nw 55th court; fort lauderdale, FL 33309 ; 954677-920
• MDR Report Key: 6623935
• MDR Text Key: 77165637
• Report Number: 1000113657-2017-00981
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00021292007836
• UDI-Public: (01)00021292007836(17)171214(10)MT1844
• Combination Product (y/n): N
• PMA/PMN Number: K140100
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 06/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: TRUEMETRIX
• Device Lot Number: MT1844
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Home
• Date Manufacturer Received: 05/10/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death