MAUDE Adverse Event Report: TRIVIDIA HEALTH, INC. N/A; BLOOD GLUCOSE SYSTEM

Model Number KETONE STRIPS

Device Problem Display Difficult to Read (1181)

Patient Problem Headache (1880)

Event Date 04/05/2019

Event Type  malfunction  

Manufacturer Narrative

(manufacturer narrative = t, corrected data = f) internal report # (b)(4).Product not returned for evaluation.Most likely underlying root cause: mlc-22-client is testing with expired test strips note: manufacturer contacted customer (several attempts) in a follow-up call to ensure that the replacement products resolved the initial concern - unable to establish contact at this time.

Event Description

Consumer reported complaint for ketone strips.The customer stated that her ketone test strips do not change color.At the time of the call the customer reported that she had a headache and flu symptoms, but were not related to diabetes as customer stated she does not have diabetes.Medical attention was not needed at the time of the call.The product storage location is undisclosed.The ketone test strip lot manufacturer's expiration date is 01/31/2020 and customer stated that she had opened the ketone strips in august of last year.

Manufacturer Narrative

(manufacturer narrative = t, corrected data = t) internal report #: (b)(4).Product not returned for evaluation.Most likely underlying root cause: mlc-22-client is testing with expired test strips note: manufacturer contacted customer (several attempts) in a follow-up call to ensure that the replacement products resolved the initial concern - unable to establish contact at this time.Initial report submitted with conclusion code 67, but the applicable is 192 (shel life/expiration exceeded).

Event Description

Consumer reported complaint for ketone strips.The customer stated that her ketone test strips do not change color.At the time of the call the customer reported that she had a headache and flu symptoms, but were not related to diabetes as customer stated she does not have diabetes.Medical attention was not needed at the time of the call.The product storage location is undisclosed.The ketone test strip lot manufacturer's expiration date is 01/31/2020 and customer stated that she had opened the ketone strips in august of last year.

• Brand Name: N/A
• Type of Device: BLOOD GLUCOSE SYSTEM
• Manufacturer (Section D): TRIVIDIA HEALTH, INC.; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 8571618
• MDR Text Key: 145257094
• Report Number: 1000113657-2019-00427
• Device Sequence Number: 1
• Product Code: JIN
• Combination Product (y/n): N
• PMA/PMN Number: K000000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2020
• Device Model Number: KETONE STRIPS
• Device Lot Number: AV438
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Home
• Initial Date Manufacturer Received: 04/05/2019
• Initial Date FDA Received: 05/01/2019
• Supplement Dates Manufacturer Received: 04/05/2019
• Supplement Dates FDA Received: 05/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SECOND THERAPY.; SECOND THERAPY.