Model Number STRIP, TMX MJR 50CT12/CASE MG/DL |
Device Problem
Image Display Error/Artifact (1304)
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Patient Problem
Burning Sensation (2146)
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Event Date 01/20/2022 |
Event Type
Injury
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Manufacturer Narrative
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Internal report reference number: (b)(4).Adverse event report is being submitted due to symptoms related to diabetes: burning feet.Meter and test strips were not returned for evaluation.Note 1: customer contacted manufacturer in follow-up call on (b)(6) 2022 - customer stated she had received the test strips and control solution; customer stated she had performed control test and result was within range.Customer did not disclose her condition at the time of the call.Note 2: manufacturer contacted customer in several follow-up calls to ensure the customer's condition improved - unable to establish contact with customer at this time.
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Event Description
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Consumer reported complaint for error message (e-3).At the time of the call the customer reported symptom of burning feet; medical attention was not needed at the time.During the call, a blood test was performed by the customer non-fasting and produced test result of 292 mg/dl using true metrix air meter; customer was satisfied with the result obtained.The product is stored according to specification in the living room.The test strip lot manufacturer¿s expiration date is 06/22/2022 test strips were opened one month prior to call.
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Manufacturer Narrative
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Sections with additional information as of 11-april-2022 h6: updated fda's type of investigation, investigation findings, and investigation conclusions.H10: meter was not returned for evaluation.Test strips were not returned for evaluation.Retention testing was performed using test strips from the same lot.Retention strips tested within specifications.Most likely underlying root cause: mlc-030: user applied blood to strip before inserting strip into meter.
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Search Alerts/Recalls
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