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

Model Number TRUEMETRIX

Device Problems Incorrect Or Inadequate Test Results (2456); High Test Results (2457)

Patient Problem Eye Injury (1845)

Event Date 05/10/2017

Event Type  malfunction  

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.Manufacturer notes: trividia health internal review for customer (b)(6) history found.Original complaint - high results compared to another meter model.-history showed 2 meters issued to mr.(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 ran# (b)(4)).(b)(6): date complaint received: ran#0(b)(4) - the customer called with concerns regarding their meter reading high.Their normal fasting glucose range is 150mg/dl to 160mg/dl.The customer denies the need for medical attention at the time of call.The customer denies having any signs or symptoms of hypoglycemia or hyperglycemia at the time of call.-meter, strips and send control solution replaced for customer satisfaction.On 03-01-2017: replacement products sent: s/n# (b)(4) strip lot# mt2256.On 03-09-2017: compliance review completed report reviewed for possible mdr by post market compliance regarding analysis of customer's results under concern.The outcome of this report will be determined based on the parkes grid analysis.Based on the customer's expected fasting blood glucose test results of 150 to 160 mg/dl and the highest fasting test result reviewed in meter memory of 221 mg/dl; the complaint is not reportable - zone b - parkes error grid.It does not meet the definition of an mdr per 21 cfr 803.3.On (b)(6)2017: follow-up call from trividia health made for mr.(b)(6) replacement meter: no response, left message for customer to call back.On (b)(6)2017: follow-up call from trividia health was made to mr.(b)(6) regarding his replacement meter (true metrix s/n (b)(4) strip lot# mt2256) mr.(b)(6) informed customer care that wife had passed away (medwatch -mfr.Report #1000113657-2017-00981).On (b)(6)2017: follow-up call from trividia health was made in an effort to ensure the customers new replacement products have resolved the customer original concerns.Spoke with customer who states that he is still having the same problem and that his meter is reading 40-60 points different from one test to the next.Customer states he is going to use competitor meter and states that he is going to throw these meters in the garbage.Customer also requests to be taken off the call back list and does not want any more calls from us.On (b)(6)2017: trividia health received a call from customer.Mr.(b)(6) who contacted customer care manager.Mr.(b)(6) complained about his original meter and replacement product and stated results are inconsistent.Customer was asked what results he was expecting when he tested and he stated "somewhere between 95 -250".He stated his "meter produced a result of 180 which is 70 points higher than the doctor's laboratory equipment".He did not mention or recall if he was fasting or not at the time of the test.Mr.(b)(6) was asked if he could please return the meters for investigation due to the importance of investigating the alleged defective products.Mr.(b)(6) declined to send the meters back for investigation at that time.Mr.(b)(6) was advised to contact customer care manager at any time should be have any questions and that company would be following up with him as part of our complaint process to get further information.5-10-2017: email notification from retailer.Manufacturer was notified about 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 was provided to mr.(b)(6) based on the information provided by retailer.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).Mr.(b)(6) 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 6-02-2017: secondary compliance review based on retailer complaint: "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 of meter "readings are all over the place" (erratic) and "meter causing his diabetes-driven eye disease", the complaint is reportable - it does meet the definition of an mdr per 21 cfr 803.3." on 6-06-2017: qc investigation evaluation: customer did not return products.Retention test performed on 5/26/2017 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: - 1000113657-2017-00981, - 1000113657-2017-00982, - 1000113657-2017-00983.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 wed.(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 diabetes-driven eye disease that he was just diagnosed with.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: 6624620
• MDR Text Key: 77396503
• Report Number: 1000113657-2017-00984
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00021292007836
• UDI-Public: (01)00021292007836(17)180531(10)MT2256
• 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: Other
• 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: MT2256
• 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