Catalog Number 07464215160 |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/05/2022 |
Event Type
malfunction
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Event Description
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The initial reporter received questionable vitamin d total g2 elecsys and vitamin d total g3 elecsys results for 14 patient samples tested on the cobas 6000 e601 module with serial number (b)(4).The reporter is questioning vitamin d v3 results compared to vitamin d v2 patient results.The initial results were reported outside of the laboratory.The samples of patients 27, 29, 35 and 37 were rerun on the module and a siemen's intellica.Patient 4 had an initial vitamin d v3 result of >120 ng/ml with a data flag.The vitamin d v2 repeat result was 77.6 ng/ml.Patient 5 had an initial vitamin d v3 result of 76 ng/ml.The vitamin d v2 repeat result was 48.5 ng/ml.Patient 10 had an initial vitamin d v3 result of 91.8 ng/ml.The vitamin d v2 repeat result was 51.8 ng/ml.Patient 13 had an initial vitamin d v3 result of >120 ng/ml with a data flag.The vitamin d v2 repeat result was 76.2 ng/ml.Patient 16 had an initial vitamin d v3 result of 62.7 ng/ml.The vitamin d v2 repeat result was 40.6 ng/ml.Patient 22 had an initial vitamin d v3 result of 67.2 ng/ml.The vitamin d v2 repeat result was 34.1 ng/ml.Patient 27 had an initial vitamin d v3 result of 117.7 ng/ml.The vitamin d v2 first repeat result from the module was 74.1 ng/ml.The second repeat result from the siemens intellica is 67.65 ng/ml.Patient 29 had an initial vitamin d v3 result of 107.3 ng/ml.The vitamin d v2 first repeat result from the module was 70.7 ng/ml.The second repeat result from the siemens intellica is 62.27 ng/ml.Patient 31 had an initial vitamin d v3 result of 115.9 ng/ml.The vitamin d v2 first repeat result was 74.8 ng/ml.Patient 32 had an initial vitamin d v3 result of 78.5 ng/ml.The vitamin d v2 first repeat result was 45.5 ng/ml.Patient 34 had an initial vitamin d v3 result of 72 ng/ml.The vitamin d v2 first repeat result was 43.9 ng/ml.Patient 35 had an initial vitamin d v3 result of 17.4 ng/ml.The vitamin d v2 first repeat result from the module was 39.5 ng/ml.The second repeat result from the siemens intellica is 15.58 ng/ml.Patient 36 had an initial vitamin d v3 result of >120 ng/ml with a data flag.The vitamin d v2 first repeat result was 75.6 ng/ml.Patient 37 had an initial vitamin d v3 result of 80.1 ng/ml.The vitamin d v2 first repeat result from the module was 54.72 ng/ml.The second repeat result from the siemens intellica is 15.58 ng/ml.No result was deemed correct.The vitamin d v3 reagent lot number is 622309 with an expiration date of dec-2022.
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Manufacturer Narrative
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The investigation is ongoing.
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Manufacturer Narrative
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The field application specialist (fas) inspected the instrument.The fas ordered reagents and performed a 40-sample method comparison to ensure that the current and updated vitamin d assays correlated.The method comparison study was within specifications.The investigation determined the service actions resolved the issue. the investigation determined that the product performance was within specifications.
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Search Alerts/Recalls
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