MAUDE Adverse Event Report: BECKMAN COULTER POS BREAKPOINT COMBO PANEL TYPE 23; MICRO DILUTION PANEL

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Not Applicable (3189)

Event Date 06/27/2015

Event Type  malfunction  

Manufacturer Narrative

Review of the submitted data from the customer did not show any obvious instrument or technique related issues and data supported the susceptible oxacillin result reported by the customer.Additional testing could not be performed on the isolate as it was no longer available.The possible cause of the reported false susceptible result could not be determined with the available information.Beckman coulter identifier for this report is (b)(4).

Event Description

It was reported that a false susceptible oxacillin result was obtained on the isolate (staphylococcus aureus) using microscan pos breakpoint combo panel type 23.The isolate was from a (b)(6) survey and the expected result was (b)(6) there was no patient involved as this was a proficiency test.

• Brand Name: POS BREAKPOINT COMBO PANEL TYPE 23
• Type of Device: MICRO DILUTION PANEL
• Manufacturer (Section D): BECKMAN COULTER; 2040 enterprise blvd; west sacramento CA 95691
• Manufacturer (Section G): BECKMAN COULTER; 2040 enterprise blvd; west sacramento CA 95691
• Manufacturer Contact: norma rahill ; 1584 enterprise blvd; west sacramento, CA 95691 ; 9163742139
• MDR Report Key: 5026747
• MDR Text Key: 24591015
• Report Number: 2919016-2015-00105
• Device Sequence Number: 1
• Product Code: JWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K862140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Report Date: 07/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Expiration Date: 12/02/2015
• Device Model Number: N/A
• Device Catalogue Number: B1017-206
• Device Lot Number: 2015-12-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1