On (b)(6) 2023, the instrument produced critical heparin (ufh) results for 4 patients :ufh = 0.00 ui/ml.When samples were reran, the results were as follow: a.Initial result: <0.10, corrected: 0.49 drawn date/time: original: (b)(6) 2023 @ 06:31 corrected: 10:00; b.Initial result: <0.10, corrected: 0.82 drawn date/time: original: (b)(6) 2023 @ 06:05 corrected: 09:29; c.Initial result: <0.10, corrected: 0.17 drawn date/time: original: (b)(6) 2023 @ 07:22 corrected: 09:36; d.Initial result: <0.10, corrected: 0.68 drawn date/time: original: (b)(6) 2023 @ 07:22 corrected: 09:39.Samples were uncapped.According to the customer, results have been released, and patient(s) received treatment or had treatment withheld based on the results reported.Diagnostica stago has received no details of treatment(s) changes.No serious injuries or deaths have been reported.
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On 2023-01-29, the customer called the hotline to report and explain the event.On 2023-01-30, a service engineer (fse) was dispatched to the customer.No instrument problem was identified (the service engineer (fse) ran qc and precision for pt, ptt, fib, ddi, and hep assays.All results were in range).On (b)(6) 2023, the customer called the hotline to report that the instrument produced 3 other critical heparin (ufh) results ufh = 0.00 ui/ml.When samples were reran, the results were as follow: pid (b)(6) => initial result was 0.0 ((b)(6) 2023 7:09) ran on another unit ((b)(4)) and resulted 0.31 ((b)(6) 2023 7:25); pid (b)(6) => initial result was 0.00 ((b)(6) 2023 7:11) ran on other unit ((b)(4)) and resulted 0.30 ((b)(6) 2023 07:38); pid (b)(6) => initial result was 0.0 ((b)(6) 2023 7:09) reran on other unit ((b)(4)) and resulted 0.45 ((b)(6) 2023 7:24).Samples were capped.According to the customer, results haven't been released.On 2023-02-10, an fse was dispatched to the customer.No instrument problems were identified (verification of needle volumes, washing wells vacuum, and temperatures.All were in range.Fse ran qc and precision for pt, ptt, ddi, fib, and hep & patient samples.All were in range).The instrument data files were collected.Investigation is on-going.Diagnostica stago will provide a follow-up report once more relevant information is available.
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