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U.S. Department of Health and Human Services

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

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ORTHO-CLINICAL DIAGNOSTICS IMMUNODIAGNOSTIC PRODUCTS CKMB REAGENT PACK IN-VITRO DIAGNOSTIC Back to Search Results
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).
 
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Brand NameIMMUNODIAGNOSTIC PRODUCTS CKMB REAGENT PACK
Type of DeviceIN-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 Key8189980
MDR Text Key131340103
Report Number3007111389-2018-00198
Device Sequence Number1
Product Code JHX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 12/21/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/21/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/29/2019
Device Catalogue Number1896836
Device Lot Number2370
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/02/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/12/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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