Model Number KIT, TRUE METRIX METERMG/DL |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/05/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Internal report reference number: (b)(6).Test strips were not returned for evaluation.Meter was returned for evaluation.Product testing was performed and no defect found.Returned meter did have results stored in the meter memory.Most likely underlying root cause: mlc-028: there was not enough information to determine the mlurc.Note: manufacturer contacted customer in several follow-up calls to ensure the replacement products resolved the initial concern - unable to establish contact with customer at this time.
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Event Description
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Consumer reported complaint that she had not used the true metrix meter but that there had already been results in the meter's memory.The customer feels well and did not report any symptoms.No medical attention associated with the use of the product was reported.The test strip lot manufacturer¿s expiration date is 10/27/2023; open vial date and product storage was not disclosed.
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Manufacturer Narrative
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Sections with additional information as of 25-aug-2022: h6: updated fda¿s type, findings and conclusions codes.H10: test strips were not returned for evaluation.Retention testing was performed using test strips from the same lot.Retention strip lot tested within specifications.Most likely underlying root cause: mlc-028: there was not enough information to determine the mlurc.
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Search Alerts/Recalls
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