Model Number 100071 |
Device Problems
Incorrect Or Inadequate Test Results (2456); Device Displays Incorrect Message (2591)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 05/02/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation conclusion: investigation pending.
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Event Description
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Report received of discrepant inratio value.Patient's therapeutic range 2.5 - 3.0.On (b)(6) 2016 inratio inr = 1.3; patient retested and received error messages.Four hours after first test, patient was tested at physician's office and the doctor's alternate poc meter inr was 3.0.No reported adverse patient sequela.
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Manufacturer Narrative
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Investigation/conclusion: it is indicated that the product is not returning for evaluation.Therefore, a review of the entire in-house testing history of the reported lot was performed.In-house strip testing on the reported strip lot meets accuracy criteria.The product performed as expected and no product deficiency was identified.A review of the manufacturing batch records for the reported strip lot did not uncover any non-conformances.The lot met release specifications.Root cause could not be determined from the information provided by the customer.Based on the information available, there is no indication of a product deficiency.No corrective action is required at this time.
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Search Alerts/Recalls
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