MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS CHEMISTRY PRODUCTS CKMB SLIDES; IN-VITRO DIAGNOSTIC

Catalog Number 8001133

Device Problems Incorrect Or Inadequate Test Results (2456); Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/22/2014

Event Type  malfunction  

Event Description

The customer reported lower than expected vitros ckmb quality control results were obtained on a vitros 250 chemistry system.Vitros ckmb results 10.6, 10.9, 11.0, 10.6, 11.8, 10.4, 10.1, 6.1, 9.7 versus 18.1 u/l.A biased result of the direction and magnitude observed may lead to inappropriate physician action if undetected.No patient samples were affected, and there was no allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc.Complaint numbers (b)(4).

Manufacturer Narrative

The investigation determined that lower than expected vitros ckmb quality control results were obtained on a vitros 250 chemistry system.The investigation concludes that the most likely cause of this event is user error due to improper vitros ckmb microslide reagent handling.The investigation determined that the vitros ckmb reagent storage conditions were not according to the recommended vitros instructions for use.Acceptable performance was obtained following replacement of the affected vitros ckmb slides with a different lot of vitros ckmb slides at the customer site.There was no indication of a systemic quality issue associated with vitros ckmb slide lot 4933-0195-3983.

• Brand Name: VITROS CHEMISTRY PRODUCTS CKMB SLIDES
• 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; 513 technology blvd.; rochester NY 14652
• Manufacturer Contact: james a stevens ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 4305923
• MDR Text Key: 5193097
• Report Number: 1319809-2014-00068
• Device Sequence Number: 1
• Product Code: JHS
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2015
• Device Catalogue Number: 8001133
• Device Lot Number: 4933-0195-3983
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2014
• 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