|
A customer complained about what was described as discrepant abo typing and antibody screening results for two patients when using their ortho vision id-mts analyzer.Date of event: (b)(6) 2021
complainant/complaint reporter: (b)(6)- laboratory supervisor
reported on 02 april 2021 by the customer to ortho care helpdesk
reagents:
lots not provided.Patient information:
patient 1 with sample 1 with id (b)(6)
patient 2 with sample 2 with id (b)(6)
the customer reported that on the (b)(6) 2021, they had tested two samples from two different patients (sample 1 and sample 2) for abo typing and antibody screening with their ortho vision id-mts analyzer and that they obtained respectively blood type o d(rh1) negative, antibody screening positive and blood type o d(rh1) positive antibody screening negative.The customer reported that they realized that both results were discrepant after the abo re check performed just after for both samples.The customer reported that this may be due to an user error during samples loading on the ortho vision id-mts analyzer and is requesting ortho to investigate on handheld scanner use during the reported events.The customer reported that neither patients had historical blood bank information at the facility at the time of testing.Once discrepancy was noted between initial specimens and retypes, testing of initial specimen was repeated on another ortho vision analyzer and also manually by a second laboratory technician.Initial results had been reported to the physician on the patients electronic health records.Once identified, corrected reports were issued to the physician and records updated.The customer reported that no harm was reported for both patients due to the reported events.
|
