MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS IMMUNODIAGNOSTICS PRODUCT CKMB REAGENT; IN-VITRO DIAGNOSTIC

Catalog Number 1896836

Device Problem High Test Results (2457)

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

Event Date 06/18/2014

Event Type  malfunction  

Event Description

The customer observed a single non-reproducible, higher than expected vitros ckmb result from a patient sample processed on a vitros 5600 integrated system.A vitros ckmb result of 25.6 ng/ml vs.Expected result of 0.54 ng/ml was obtained from the sample.A biased result of the direction and magnitude observed may lead to inappropriate physician action if undetected.The non-reproducible, higher than expected ckmb result was reported from the laboratory, however, a corrected report was issued and no treatment was given, changed, or withheld based on the reported ckmb result reported.There was no allegation of patient harm.(b)(4).

Manufacturer Narrative

The investigation confirmed that a non-reproducible, higher than expected vitros ckmb result was obtained from a patient sample processed on the vitros 5600 system.The investigation could not determine a definitive root cause.There was no indication the vitros 5600 system or the vitros ckmb reagent contributed to the event.Additionally, it is unknown if the sample was processed in accordance with the tube manufacturer¿s recommendations.It is possible that cellular debris, due to poor sample preparation, was present in the affected sample, although this could not be confirmed.A definitive root cause for the event could not be determined.

• Brand Name: VITROS IMMUNODIAGNOSTICS PRODUCT CKMB REAGENT
• 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: 3943404
• MDR Text Key: 4641215
• Report Number: 3007111389-2014-00160
• 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: 07/18/2014

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: 11/21/2014
• Device Catalogue Number: 1896836
• Device Lot Number: 1670
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/19/2014
• Initial Date FDA Received: 07/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1