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.Per product labeling, "coaguchek uses human recombinant thromboplastin.Therefore, the comparability to other human recombinant thromboplastins is best, whereas higher deviations can occur with other thromboplastins.However, those higher differences between thromboplastins of different (rabbit, bovine based) origin are not a coaguchek specific issue.Similar differences can be observed when a human recombinant thromboplastin-based laboratory method is compared against several other (rabbit, bovine-based) laboratory methods." occupation was patient/consumer.
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There was an allegation of questionable results from coaguchek xs meter serial number (b)(4).The reporter alleged she had two cardioversions rescheduled after the meter results were in her therapeutic range, but the laboratory results were lower.On (b)(6) 2021, the result reported to be from the meter was 2.7 inr.The reporter did not recall whether changes were made to her warfarin dose, but did not believe anything changed since the result was in range.On (b)(6) 2021, the scheduled day of the cardioversion, the result from the hospital laboratory using stago reagent was reported to be 1.8 inr.Therefore, allegedly they would not perform the cardioversion.Allegedly, the patient was sent home and was instructed to be in range for three weeks before the procedure.No meter comparison results were performed on (b)(6) 2021.The reporter alleged she was in afib the whole time and was having her inr tested at the hospital laboratory.No specific results were provided.The cardioversion was performed on (b)(6) 2022.The patient alleged that since this date, she had been going into afib about once per month.On (b)(6) 2022, the result reported to be from the meter was 2.4 inr.On (b)(6) 2022, the result reported to be from the hospital laboratory using stago reagent was 2.0 inr.On (b)(6) 2022, the patient was scheduled for a second cardioversion.They were allegedly unable to perform the procedure as the result from the hospital laboratory using stago reagent was 1.9 inr.The patient was reportedly sent home without cardioversion.No meter comparison results were performed on (b)(6) 2022.On (b)(6) 2022, the patient was to have a tee done to check for clots since she was below her range.Allegedly, no clots were found, so the cardioversion was performed on (b)(6) 2022.Since this time, the patient and her doctor have reportedly been increasing her therapeutic range on the meter from 2.0-3.0 inr to 2.5- 3.5 inr.The patient tests every two weeks.The patient's current condition was reported as stable.
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