VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK 6801042

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-23 for VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK 6801042 manufactured by Ortho-clinical Diagnostics.

Event Text Entries

[126380008] 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


[126380009] 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 three of four mdr? S for this event. Four 3500a forms are being submitted for this event as four devices were involved. (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3007111389-2018-00162
MDR Report Key7994340
Date Received2018-10-23
Date of Report2018-12-17
Date of Event2018-09-24
Date Mfgr Received2018-09-24
Device Manufacturer Date2018-07-09
Date Added to Maude2018-10-23
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. JAMES A STEVENS
Manufacturer Street100 INDIGO CREEK DRIVE
Manufacturer CityROCHESTER NY 14626
Manufacturer CountryUS
Manufacturer Postal14626
Manufacturer Phone5854533000
Manufacturer G1ORTHO CLINICAL DIAGNOSTICS
Manufacturer StreetFELINDRE MEADOWS PENCOED
Manufacturer CityBRIDGEND, WALES CF355PZ
Manufacturer CountryUK
Manufacturer Postal CodeCF35 5PZ
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameVITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK
Generic NameIN-VITRO DIAGNOSTIC
Product CodeDDR
Date Received2018-10-23
Catalog Number6801042
Lot Number1375
Device Expiration Date2019-06-13
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerORTHO-CLINICAL DIAGNOSTICS
Manufacturer Address100 INDIGO CREEK DRIVE ROCHESTER NY 14626 US 14626


Patients

Patient NumberTreatmentOutcomeDate
10 2018-10-23

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