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

Catalog Number 8001133

Device Problem Low Test Results (2458)

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

Event Date 10/09/2014

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 qc result = 13.9, 13.0, 7.0 u/l vs expected result of 20.1 u/l.A biased result of the direction and magnitude observed may lead to inappropriate physician action if undetected.No patient samples were tested during this time period.There was no allegation of patient harm as a result of this event.This report is number three of three mdr¿s for this event.Three 3500a forms are being submitted for this event as three devices were involved.(b)(4).

Manufacturer Narrative

The investigation determined that lower than expected vitros ckmb quality control results were obtained on a vitros 250 chemistry system.After recalibrating the same vitros ckmb reagent lot, acceptable quality control performance was observed using a fresh quality control sample.The investigation concludes that the most likely cause of this event is a suboptimal calibration issue.The cause of the suboptimal calibration is unknown.An instrument issue, reagent issue or a fluid issue could not be ruled out as contributing factors.

• 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: 4224634
• MDR Text Key: 5072009
• Report Number: 1319809-2014-00056
• Device Sequence Number: 1
• Product Code: JHS
• Combination Product (y/n): N
• Reporter Country Code: RP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date: 11/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2015
• Device Catalogue Number: 8001133
• Device Lot Number: 4932-0191-8710
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2013
• 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