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Investigation details: the instrument is not connected to allow for further remote troubleshooting and the customer refused to provide further detail.Customer would not provide card information or card image to inspect for debris or defect.Customer did not indicate any instrument error codes at the time of this event.Ortho field service was dispatched to further evaluate the instrument.Due to the nature of the reported issue, the field engineer performed cims cleaning, cims calibration, and cims health check.Calibration and health check passed with no issues.Pipa ¿p/o¿ encoder calibration and liquid system fill were performed.No abnormal observations noted.The volume verification test to verify the fluidics system operation was performed successfully.System was rebooted into application software without issue.During troubleshooting of the instrument, no indicators were found that would contribute to the reported event.(service order 5428627) as part of the investigation, a batch record review of mts abd monoclonal and reverse card lot 033023037-13, expiry 02feb2024, was performed and no discrepancies were discovered.All in-process and final release serological testing results were within specifications, including customer use ortho vision testing results.All qc inspection records (packaging and gel card inspection documents) of this product lot indicated acceptable results; no gel card defects were identified during qc inspection.All id-mts gel cards used during in-process qc testing passed the visual checks performed by the serologist.Formulation stage batch records (anti-a lot 031623039, anti-b lot 031623040 and anti-d lot 031623041) associated with this id-mts gel card lot were reviewed and no discrepancies were discovered.The equipment area use log used during production of this lot was reviewed and no conditions or actions taken were found to directly contribute to this customer complaint.There were no product nonconformances related to this lot.The lot met all specifications, all in-process and product release criteria.(dra603366) retains testing of mts abd monoclonal and reverse card lot 033023037-13, expiry 02feb2024, was requested to verify reagent continues to function as expected.The investigation identified that mts a/b/d monoclonal and reverse grouping card lot#033023037-13 performed as intended.The card lot was tested on the ortho vision analyzer with diluent 2 plus lot#mdp221, 0.8% affirmagen lot#8a646, albaq-chek lot#v263803 and donor 713617(v51413) group o rh-.All results were as expected.A total of 100 retention cards were visually inspected and 5 cards were found to have low liquid level.However, splashing under the foil was observed.No customer return cards were received for inspection by mts.Product testing with retain cards performed as expected.No discrepant results were obtained with albaq-chek and donor samples.Retain testing was unable to confirm customer complaint.Mts a/b/d monoclonal and reverse grouping card lot#033023037-13 performed as intended.(dra603365) no further investigation was performed on this incident.The camera misread event reported by the customer could not be confirmed.The potential assignable cause of the discordant positive anti-a well reaction of the abo forward testing for the patient could not be determined.There was no evidence of any systematic failure of the ortho analyzer to perform as intended.No further complaint of this type has been received from the customer since the time of the reported event.
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(b)(6) ra603367 on 07sep2023, a customer contacted the global technical solutions center (gtsc) to report a cassette imaging subsystem (cims) misread of their ortho vision id-mts (serial number: (b)(6)) during aborh typing of one patient sample.Complainant: (b)(6).(customer refused to provide surname) complainant phone: (b)(6).Complainant email: (customer refused to provide) complainant title: medical technologist customer number: 2974 - (b)(6) medical, date of the event: (b)(6) 2023, reported same day.Vision 50004166, sw version 5.13.2.47027 (installed (b)(6) 2022) udi: (b)(4).Reagents: mts abd monoclonal and reverse card lot 033023037-13, expiry 02feb2024.No additional details provided.Sample id: not provided.Patient information: none provided.The customer stated that on 07sep2023, one patient sample was tested for aborh and reverse.The vision reported the result as positive 1+ for the forward anti-a column.Upon visual inspection, the customer manually read the result as negative.The customer indicated the vision also posted cnf flags for the anti-b and anti-d columns of the same gel card.Customer did not provide reverse grouping column results.No valid blood type was issued by the vision and the customer rejected the column results and archived the card results.No biased result was reported to the physician.No patient was harmed because of this event.
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