Model Number KIT, TRUE METRIX METERMG/DL |
Device Problem
Battery Problem (2885)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/24/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Internal report reference number: (b)(4).Test strips were not returned for evaluation.Meter was returned for evaluation - defect found on returned meter - battery contacts corroded.Product evaluation has been completed.Returned product was forwarded to r&d meter for root-cause.R&d investigation has been completed and root cause selected.Root cause: rc-041: user/mechanical stress.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 the battery corroded in the true metrix meter.Mother is calling on behalf of the customer.Customer stated that there was "brown and green stuff melted in the meter" and that she is unable to use it.Customer stated she has been using the true metrix meter for a year.The customer feels well and did not report any symptoms.No medical attention associated with the use of the product was reported.The product is not stored according to specification: customer stated that the meter and test strips are being stored in the kitchen.
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Manufacturer Narrative
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Sections with additional information as of 14-oct-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.Root cause: rc-041: user/mechanical stress.
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Search Alerts/Recalls
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