Catalog Number 07671687016 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/22/2023 |
Event Type
malfunction
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Manufacturer Narrative
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A retention meter was sent to the customer.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.Product labeling states: "the coaguchek system uses human recombinant thromboplastin.Therefore, the comparability to other human recombinant thromboplastins is best, whereas deviations can occur when compared to methods using other thromboplastins.However, those deviations between thromboplastins of different origin (e.G., rabbit based) are not specific to coaguchek products.Similar differences can be observed when a human recombinant thromboplastin-based laboratory method is compared to other laboratory methods." section e3: occupation is patient/consumer.
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Event Description
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A customer stated they received discrepant results when testing with a coaguchek inrange meter.A sample from the patient was tested in the laboratory using the stago method, resulting in a value of 4.50 inr.Within 3 hours of laboratory testing, a sample from the patient was tested using the meter, resulting in a value of 6.1 inr.On (b)(6) 2023, a sample from the patient was tested in the laboratory using the stago method, resulting in a value of 4.03 inr.Within 3 hours of laboratory testing, a sample from the patient was tested using the meter, resulting in a value of 5.5 inr.On (b)(6) 2023, a sample from the patient was tested in the laboratory using the stago method, resulting in a value of 4.4 inr.Within 3 hours of laboratory testing, a sample from the patient was tested using the meter, resulting in a value of 6.4 inr.The patient's therapeutic range is 3 - 4 inr.
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Manufacturer Narrative
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The customer was provided a loaner coaguchek inrange meter (serial number unknown) and received additional discrepant values.On (b)(6) 2023, a sample from the customer's meter resulted in a value of 5.6 inr.At an unknown time on the same day, a sample from the patient was tested using the loaner meter, resulting in a value of 5.2 inr.At an unknown time on the same day, a sample from the patient was tested in the laboratory, resulting in a value of 4.1 inr.On (b)(6) 21023, a sample from the customer's meter resulted in a value of 4.4 inr.At an unknown time on the same day, a sample from the patient was tested using the loaner meter, resulting in a value of 4.5 inr.At an unknown time on the same day, a sample from the patient was tested in the laboratory, resulting in a value of 3.46 inr.
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Search Alerts/Recalls
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