MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB CALIBRATORS; IN-VITRO DIAGNOSTIC

Catalog Number 1286293

Device Problem High Test Results (2457)

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

Event Date 01/26/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation confirmed that higher than expected vitros ck-mb results were obtained for non-vitros qc fluids processed using vitros ck-mb reagent lot 2240 on a vitros 5600 integrated system (s/n (b)(4)).The assignable cause was determined to be a sub-optimal vitros ck-mb calibration as the qc performance was unacceptable immediately after a calibration event.The cause of the sub-optimal calibration could not be determined, although a pre-analytical handling or storage issue could not be completely ruled out.Based on historical quality control results, a vitros ck-mb reagent lot 2240 performance issue is not a likely contributor to this event.Following re-calibration of vitros ck-mb lot 2240 using the same reagent pack and a fresh set of calibrator fluids, acceptable qc performance was obtained.

Event Description

The customer observed higher than expected vitros ck-mb quality control results obtained from non-vitros quality control (qc) fluids processed using vitros ck-mb reagent on a vitros 5600 integrated system.Cliniqa cardiac marker control level 1, lot 170616, results 4.52, 4.96 and 4.99 ng/ml, versus expected result 3.15 ng/ml biased results of the direction and magnitude observed may lead to inappropriate physician action if undetected.No erroneous patient sample results were obtained or reported from the laboratory.Ortho was not made aware of any allegation of patient harm as a result of this event.(b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB CALIBRATORS
• 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: 7295270
• MDR Text Key: 101151215
• Report Number: 3007111389-2018-00025
• Device Sequence Number: 1
• Product Code: JIS
• 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: Medical Technologist
• Type of Report: Initial
• Report Date: 02/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/29/2018
• Device Catalogue Number: 1286293
• Device Lot Number: 2240
• Other Device ID Number: 10758750008728
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2017
• 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