Model Number STRIP, SUNMARK TMX 100CTMG/DL |
Device Problem
Product Quality Problem (1506)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/14/2022 |
Event Type
malfunction
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Event Description
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Consumer reported complaint for physical defect of test strips.Customer stated that the true metrix test strips were not fitting correctly into the true metrix meter.Customer stated that when she inserts the strip into the meter, the meter does come on however the strip is "not hitting the back of the internal meter correctly and feels that they are not cut correctly." customer advised that there was no damage to the product packaging when it was purchased and seal was intact.The test strip lot manufacturer¿s expiration date is 07/28/2023; product storage and open vial date were not disclosed.The customer feels well and did not report any symptoms.No medical attention associated with the use of the products was reported.
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Manufacturer Narrative
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(b)(4).Test strips were not returned for evaluation - customer had returned an empty test strip vial.Note: manufacturer contacted customer in a follow-up call on 27-sep-2022 to ensure the replacement products resolved the initial concern - able to establish contact with customer who stated replacement products resolved initial concern.
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Manufacturer Narrative
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Sections with additional information as of 03-nov-2022: h6: updated fda¿s type, findings and conclusions codes.H10: test strips were not returned for evaluation - customer had returned an empty test strip vial, unable to test.Retention testing was performed using test strips from the same lot.Retention strip lot passed within specifications.Complaint was forwarded to production operations and internal evaluation was completed.No abnormalities observed.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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