Model Number 100071 |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); Incorrect Or Inadequate Test Results (2456)
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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 12/03/2015 |
Event Type
Injury
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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 values.Patient's therapeutic range 2 - 3; (b)(6) 2015 inratio inr = 7.5; (b)(6) 2015 inratio inr = 1.4; repeat inratio inr = 1.5; no reported adverse patient sequela.
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Manufacturer Narrative
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On (b)(6) 2015 inratio inr = 2.5.On (b)(6) 2015 inratio inr = 7.5 warfarin held and vitamin k administered two drops of blood used for testing.On (b)(6) 2015 inratio inr = 1.4 two drops of blood used for testing; repeat inratio inr = 1.5.(b)(4).
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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 lot was performed.In-house testing on strip lot 365429a was found to be performing within expectations.A review of the manufacturing records for the lot did not uncover any non-conformances.The lot meets release specification.Although an improper technique was identified in the complaint, a root cause could not be determined from the information provided.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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