MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS IMMUNODIAGNOSTIC PRODUCTS CKMB REAGENT PACK; IN-VITRO DIAGNOSTIC

Catalog Number 1896836

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/02/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation concluded that multiple lower than expected vitros myog quality control results and multiple higher than expected vitros ckmb quality control results were obtained using non-vitros biorad quality control fluids in combination with a vitros 5600 integrated system.The assignable cause for the higher and lower than expected biorad qc fluid results could not be determined with the information provided by the customer.There was no evidence to suggest a vitros 5600 integrated system malfunction; however, it cannot be entirely ruled out as a contributing factor as the same quality control fluids generated acceptable results on an alternate vitros eci system on site.Additionally, based on multiple historical vitros reagent quality control results, and since the same reagent lots generated acceptable quality control results on an alternate vitros eci system, there is no indication a reagent related issue contributed to the event.Continual tracking and trending of complaints has not identified any signals that would point to potential systemic issues with vitros product ckmb, lot 2370 or myog lot 1365.Finally, it is unlikely a biorad quality control sample related issue as the same control fluids generated acceptable results on an alternate vitros eci system.

Event Description

The investigation has determined that higher than expected vitros ckmb results were obtained from non-vitros biorad l1 qc fluid using vitros immunodiagnostics product ck-mb reagent on a vitros 5600 integrated system and lower than expected vitros myog results were obtained from a non-vitros biorad qc fluid using vitros immunodiagnostics product myoglobin reagent on a vitros 5600 integrated system.Biorad cardiac marker plus lot 23690 l1 qc fluid (ckmb) results of 4.81, 4.81, 4.79, 4.81 and 4.87 ng/ml versus the expected result of 3.026 ng/ml.Biorad cardiac marker plus lot 23690 l1 qc fluid (myog) results of 68.49, 70.30, 72.68, 74.55, 94.93, 98.74, 99.25, 99.81, 101.83, 101.83, 102.72, 103.78, 104.04, 106.31, 107.05, 110.14, 111.28, 111.48, 112.23, 112.62, 113.0, 113.98, 114.38, 114.43, 114.93, 115.84, 116.55, 117.28, 117.92, 118.42, 118.89, 119.31, 119.85 and 120.28 miu/ml versus the expected result of131.6 miu/ml.A biased result of the direction and magnitude observed may lead to inappropriate physician action if it were to occur undetected with patient samples.Ortho has not been made aware of any erroneous vitros myog or ckmb patient sample results obtained or reported from the laboratory over the time frame of the event; however, the investigation cannot conclude that patient sample results were not affected or would not be affected if the event were to recur undetected.There was no reported allegation of patient harm as a result of this event.This report is number one of two 3500a forms filed for this event, as two devices were affected.This report corresponds to ortho clinical diagnostics (ortho).Complaint number (b)(4).

• Brand Name: IMMUNODIAGNOSTIC PRODUCTS CKMB REAGENT PACK
• Type of Device: IN-VITRO DIAGNOSTIC
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS; 100 indigo creek drive; rochester NY 14626
• Manufacturer (Section G): ORTHO CLINICAL DIAGNOSTICS; felindre meadows; pencoed; bridgend, wales CF35 5PZ; UK CF35 5PZ
• Manufacturer Contact: james a stevens ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 8189980
• MDR Text Key: 131340103
• Report Number: 3007111389-2018-00198
• Device Sequence Number: 1
• Product Code: JHX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/29/2019
• Device Catalogue Number: 1896836
• Device Lot Number: 2370
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/02/2018
• Initial Date FDA Received: 12/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1