MAUDE Adverse Event Report: TRIVIDIA HEALTH INC KETONE TEST STRIPS; NITROPRUSSIDE, KETONES (URINARY, NON-QUANT.)

Model Number STRIP, WALGREENSKETONE 50CT #496636

Device Problem Product Quality Problem (1506)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/23/2020

Event Type  malfunction  

Manufacturer Narrative

Internal report reference number: (b)(4).Ketone test strips were not returned for evaluation, most likely underlying root cause: mlc-50: manufacturing or packaging process caused malfunction of user's test strip.Note: manufacturer contacted customer in a follow-up call on to ensure the replacement products resolved the initial concern - unable to establish contact with customer at this time.

Event Description

Consumer reported complaint for defect of ketone test strips.The customer stated when she had opened the vial, all of the padding on the ketone strips was gray.The package had not been open or damaged when received.The customer declined to perform a urine test at the time of the call, stating that she had attempted to test three times.The customer feels well and did not report any symptoms.No medical intervention associated with the use of the product was reported.

Manufacturer Narrative

Corrected sections as of 19-nov-2020: d2: common device name corrected from system, test blood glucose, over the counter to nitroprusside, ketones (urinary, non-quant.).Sections with additional information as of 19-nov-2020: h6: updated fda's method, result, and conclusion codes.H10: ketone test strips were returned for evaluation, defect was detected: physical defect of strips; discolored grey pads.Retention results are acceptable.Most likely underlying root cause: rc-061 storage outside specifications.Note: manufacturer contacted customer in a follow-up call 20-oct-2020 to ensure the replacement products resolved the initial concern - able to establish contact with customer and stated replacement product resolved initial concern.

• Brand Name: KETONE TEST STRIPS
• Type of Device: NITROPRUSSIDE, KETONES (URINARY, NON-QUANT.)
• Manufacturer (Section D): TRIVIDIA HEALTH INC; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 10705272
• MDR Text Key: 234676003
• Report Number: 1000113657-2020-00766
• Device Sequence Number: 1
• Product Code: JIN
• UDI-Device Identifier: 021292008178
• UDI-Public: (01)021292008178
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 11/19/2020

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: 09/16/2021
• Device Model Number: STRIP, WALGREENSKETONE 50CT #496636
• Device Lot Number: AX566
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2020
• Distributor Facility Aware Date: 09/23/2020
• Initial Date Manufacturer Received: 09/23/2020
• Initial Date FDA Received: 10/20/2020
• Supplement Dates Manufacturer Received: 10/27/2020
• Supplement Dates FDA Received: 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1