Nova biomedical was notified of a potential issue regarding the hemoglobin and hematocrit results obtained from 5 different devices.Additional information was received after the 30 day timeline, since,thailand was still on lockdown due to covid which made communication with the hospital difficult.An on-site service call could not be done due to the shutdown.An additional contributory factor in the delay in communication was due to chinese new year.In the process of attempting to obtain further information it was identified that sample collection technique was found to be at issue.It was noted that the customer is not using the correct anticoagulant for samples as indicated in the ifu.At present, we are unable to ascertain what values were obtained from what specific device.Nova biomedical is attempting to obtain additional information to clarify.A supplemental report shall be submitted upon receipt of additional information.There was no report of patient harm or any intervention required.
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Udi: (b)(4).Dhr review for stat profile prime plus microsensor cards, lots 21344062 and 21327067, were completed by a quality control manager and no issues were identified.Dhrs indicated that the released product met all specifications and no issue was identified.Due to covid restrictions in thailand, nova was not able to go on-site to investigate the reported issue.The reported problems were reviewed within nova r&d.As an output of this review, nova initiated additional development work to enhance the overall performance of the prime plus sensor cards.Replacement sensor cards were also sent to the customer and no similar issues have since been reported.A review of post market data was performed by nova's pmd manager, and no other similar issues have been received for either lot of sensors cards.
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