Catalog Number 04625374160 |
Device Problems
High Test Results (2457); Non Reproducible Results (4029)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/05/2023 |
Event Type
malfunction
|
Event Description
|
There was an allegation of a questionable result from the coaguchek xs meter.At 10:47 am, the result was 7.7 inr.At 11:15 am, the result was 5.9 inr.The therapeutic range was 2.0-3.0 inr.The patient alleged his diet has changed due to the holidays.No specific details were provided.
|
|
Manufacturer Narrative
|
The meter serial number was (b)(6).The patient's products were requested for return.The product has not been received at this time.If the product is returned in the future, a follow-up report will be submitted.On a regular basis, coaguchek strips of lots currently valid in the market are tested as part of routine retention testing and results have passed the internal inspection.E3 - occupation was patient/consumer.
|
|
Manufacturer Narrative
|
The investigation did not identify a product problem.The customer stated they were taking antibiotics during the affected time frame.Per product labeling, when other medications, like antibiotics, are taken simultaneously it can lead to either an increase or a decrease in prothrombin time.
|
|
Search Alerts/Recalls
|