Model Number STRIP, KETONE 50CT |
Device Problem
Unsealed Device Packaging (1444)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/19/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Internal report reference number: (b)(4).Ketone test strips were returned for evaluation.Evaluation in process.Note: manufacturer contacted customer in a follow-up call on (b)(6) 2021 to ensure the replacement products resolved the initial concern-able to establish contact with customer.Customer stated initial concern has been resolved and they are satisfied with the replacement.
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Event Description
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Consumer reported complaint for the ketone test strips.Customer stated she had purchased 100 count (two vials of 50) of the ketone test strips and one of the test strip vials had been partially open when received.Customer stated that the box/seal did not appear to be tampered with.The customer is using the product for the first time out of this package.Customer had tested using test strips from the vial (negative).The customer feels well and did not report any symptoms.No medical attention related to the use of the product was reported.
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Manufacturer Narrative
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Sections with additional information as of 07-jan-2022: h3: device evaluated by manufacturer.H6: updated fda¿s type, findings and conclusions codes.H10: returned product was forwarded for internal evaluation.The packaging records were reviewed.The review of the work order showed no abnormalities.All the required sign offs for quality checks were completed by packaging and quality control.Due to the fact that ketone vials are manually packed it is believed that the vial became open after leaving trividia health facility.Ketone strips were returned for evaluation.Defect found on returned strips: physical defect of strips; discolored grey pads.Retention testing was performed using test strips from the same lot.Retention strips tested within 6 months passed within specifications.Root cause: rc-078: improperly shipped.
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Search Alerts/Recalls
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