VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK 6801042

[126373133] The investigation confirmed lower than expected vitros myoglobin quality control results were obtained using a non-vitros quality control fluid in combination with two different reagent lots on two different vitros 5600 integrated systems. A definitive assignable cause of the event could not be determined. Multiple precision tests performed indicated that the vitros 5600 systems were performing as intended. The lower than expected vitros myog quality control results were reproducible across two vitros 5600 systems, therefore, an instrument related issue did not likely contribute to the event. An unknown issue related to the cliniqa controls in use, or the vitros myog reagent or calibrators could not be ruled out as contributing to the event. Additionally, improper fluid handling of the calibrators or cliniqa control fluids could not be ruled out as contributing to the event. A definitive assignable cause of the event could not be determined.
Patient Sequence No: 1, Text Type: N, H10

[126373134] A customer obtained lower than expected vitros myoglobin quality control results using a non-vitros quality control fluid in combination with two different reagent lots on two different vitros 5600 integrated systems. Vitros myoglobin reagent lot 1365: cliniqa lot 1804042 l1 results of 54. 5, 54. 5, 53. 9, 54. 3, 53. 1, 54. 5, 52. 9, 53. 9, 53. 3, 53. 2, 53. 0, 53. 8, 53. 8, 54. 8, 55. 0, 53. 5, 55. 0, 53. 5, 53. 4, 53. 5, 53. 7, 54. 1, 54. 2, 53. 4, 52. 6, 52. 5, 53. 7, 51. 4, 52. 2, 52. 6, 51. 9, 51. 5, 52. 5, 52. 7, 54. 3, 54. 6, 53. 6, 50. 8, 51. 1, 51. 6, 51. 0, 51. 0, 51. 4, 51. 8, 51. 0, 51. 1, 52. 0, 52. 1, 52. 8, 52. 6, 52. 4, 51. 5, 52. 6, 50. 3, 51. 0, 52. 2, 51. 4, 50. 1, 52. 1, 52. 1, 50. 6, 50. 7, 50. 9, 50. 7, 51. 2, 51. 0, 51. 4, 49. 9, 50. 6, 51. 1, 51. 2, 50. 3, and 50. 5 ng/ml vs. The expected result of 65. 1 ng/ml. Vitros myoglobin reagent lot 1375: cliniqa lot 1804042 l1 results of 53. 6, 54. 3, 53. 4, 51. 6, 51. 6, 51. 1, 51. 4, 50. 6, 51. 8, 50. 0, 50. 7, 50. 3, 50. 6, 49. 9, 50. 5, 50. 4, 50. 6, 51. 6, 52. 7, 52. 1, 53. 0, 51. 6, 51. 6, 52. 5, 52. 6, 53. 4, 53. 7, 53. 1, 53. 5, 52. 8, 53. 1, 53. 3, 54. 2, and 53. 0 ng/ml vs. The expected result of 65. 1 ng/ml. Biased results of the direction and magnitude observed may lead to inappropriate physician action if undetected. The lower than expected vitros myoglobin results were generated from a non-patient fluid, however the investigation cannot conclude that patient sample results would not be affected if the event were to recur undetected. Ortho has not been made aware of allegation of actual patient harm as a result of the event. This report is number four of four mdr? S for this event. Four 3500a forms are being submitted for this event as four devices were involved. This report corresponds to ortho clinical diagnostics inc (ortho). Complaint numbers (b)(4).
Patient Sequence No: 1, Text Type: D, B5