Catalog Number 04625374160 |
Device Problem
Non Reproducible Results (4029)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/14/2023 |
Event Type
malfunction
|
Event Description
|
There was an allegation of questionable results from the coaguchek xs meter.The results from the patient's meter were 5.2 inr and 5.6 inr.The results from an unknown roche "clinic meter" were 4.2 inr and 4.2 inr.All tests were performed within four hours.
|
|
Manufacturer Narrative
|
The meter serial number was (b)(6).The meter and strips have been 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 reporter¿s meter was provided for investigation where it was tested using retention strips and retention controls.Level 1 testing results (qc range = 1.0 - 1.4 inr): qc 1: 1.3 inr.Level 2 testing results (qc range = 2.2 - 3.4 inr): qc 2: 2.9 inr.The obtained qc values were in the allowed range of the used combination strip lot - qc lot.All measurements were without error messages.The results alleged by the customer were not observed in the meter¿s patient result memory.
|
|
Search Alerts/Recalls
|