Catalog Number 04625374160 |
Device Problem
High Test Results (2457)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/09/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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The customer received questionable results from coaguchek xs meter serial number (b)(4).The customer received an error "6" and then got a result of 8.0 inr at 1:11 pm using strip lot 12804321.Refer to the medwatch with patient identifier (b)(6) for this lot of test strips.It was determined the meter was incorrectly coded, so the customer recalibrated to a new strip lot, 15288521.The customer retested within one hour with a new finger and the result was 6.0 inr.The customer was to follow up with his physician regarding the results as he did not think either result was accurate.There was no adverse event.The therapeutic range was 2-3 inr.The patient was not anemic, was not on heparin or a direct thrombin inhibitor, and had no antiphospholipid antibodies.The strips were requested to be returned for investigation.
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Manufacturer Narrative
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Relevant retention test strips (lot 152885-21) were tested in comparison with the current master lot coaguchek xs pt test strip (lot 124158-80).For this purpose two human blood samples from marcumar donors and two internal reference meters were used.No error messages occurred.Retention samples were acceptable and retention material performed as specified.
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Manufacturer Narrative
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The returned strips and a retention meter were tested in comparison to a retention meter and masterlot strips.Two human blood samples from warfarin donors and internal reference meters were used.Donor inr: 2.3 inr and 2.6 inr, donor hct: 46% and 43%.Donor 1: master lot / customer strip and retention meter, 2.3 inr/ 2.1 inr.Donor 2: master lot / customer strip and retention meter, 2.6 inr / 2.4 inr.All inr values were within the specified maximum difference between measurements.No error messages occurred.The returned and the retention material met the specification.No error 6 messages or other error messages occurred.As stated in the operator manual error 6 may indicate extremely high coagulation times (> 10 inr,< 5% quick).If "error 6" is displayed repeatedly, the result must be checked using another method.
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Search Alerts/Recalls
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