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Mxp#2512159 windchill ra601537 problem statement and description: customer reporting discrepant aborh result from patient resulting as abpos ten days ago during admission.Patient came back to hospital and second sample tested on different vision analyzer resulted bpos.Additional sample collected and original ten-day old sample tested on same vision and manually in tube resulted bpos relevant information: issue started on: (b)(6) 2023, reported (b)(6) 2023.Reaction grade obtained: original on (b)(6) 2023.Abpos customer was expecting: new patient.Incubation time (for manual test only): 15 minutes test repeated: manually in tube and on second vision analyzer, both reported bpos method/result obtained by repeating: alternate vision number of samples affected? was qc affected? no, qc passed.Was any expired product used? no.When was the last successful qc run? 03/20/2023.Patient was not transfused during date range of discrepant result, transfusion history: never transfused product handling protocol: cassette/gel card storage temperature range: room temp.Cassette/gel card orientation: normal.Rbc storage and handling: fridge temp.Visual appearance before use: normal.Was the vial freshly opened? no actions already performed by customer: repeated testing manually in tube and on second analyzer troubleshooting steps performed by tsc: tss looked at column grade report tsc confirmed the results from 3/10 for both samples in question to be abpos bar code scan report reviewed and determined that sample a was identified using the handheld scanner with no bar code present after the door was closed.A second sample was in position three with no bar code and no handheld scanned registered.Review of the metering report determined that sample a was pipetted at 12:32.In review of the bar code scan report again showed that sample a was again read by the hand scanner but placed in position 3.Sample id b was loaded in position 1 and the laser scanner read this id.In review of the metering report sample b was pipetted at 12:38 in position 1.Tsc has concluded that the most probable cause of the abo discrepancy was improper use of the hand scanner where sample b was physically placed in position 1 but sample a was scanned in that position.Tsc reviewed this data with customer.Customer indicates their understanding and agreement of the events.Customer is confident that discrepancy is user error, and the vision and products are functioning as expected.Customer has agreed to callback with any questions or concerns.
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Investigation details: customer indicated sample a results were found to be discrepant from initial testing on (b)(6) 2023 to repeat collections on (b)(6) 2023.Repeat testing of (b)(6) 2023 on alternate vision analyzer and in manual tube method also indicated discrepant results for sample.Ortho care tsc reviewed sample column grade reports, raw barcode scan report and sample metering report.Sample column grade report identified two samples resulted during the testing period with a forward type result of ab positive.It was identified in the raw barcode scan report that sample a was manually identified with handheld scanner into position one of rack.After door was closed, no barcode was present in this position, and a sample was identified in position three also with no barcode identified.Review of the metering report determined that sample a was pipetted at 12:32.Subsequent entries of the barcode scan report showed that sample a was again read by the hand scanner but placed in position 3.Sample b was loaded in position 1 and the internal laser scanner read this id.The metering report determined that sample b was pipetted at 12:38 in position 1.Investigation of vision reports by tsc has concluded that the most probable cause of the abo discrepancy was improper use of the hand scanner where sample b was physically placed in position 1 but sample a was scanned in that position.Customer was provided with findings and referred to customer letter (cl2022-099).The customer letter further discusses the identified possible issue when utilizing ¿assign to position¿ function which will allow user to manually load samples, but if the instrument detects an alternate barcode in the assigned position, the actual barcode is not utilized, and the sample id entered using the ¿assign to position¿ function will be associated with the testing of the sample in that position.A complaint review was performed on vision 50003311 from (b)(6) 2021 through (b)(6) 2023.No additional complaints were reported for discres, falseneg, falsepos or other relevant call areas.Sample results were reported to provider initially.Corrected reports were issued once discrepancy was identified ten days later.Customer confirmed patient had not been transfused during this period.No patient was harmed.The assignable cause is associated with user error, the customer utilized the ¿assign to position¿ function on the vision software but placed the samples in the incorrect positions within the rack.No general product failure is identified.The customer has reported no other similar incident since monitoring period.
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