MAUDE Adverse Event Report: BECKMAN COULTER NEG BREAKPOINT COMBO 47; MICRO DILUTION PANEL

Model Number N/A

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Patient Involvement (2645)

Event Date 02/12/2015

Event Type  malfunction  

Event Description

It was reported that upon initial test of the (b)(6) an identification of leminerolla sp 93.14% was obtained.Upon notification from (b)(6) of the incorrect result, 4-panels were set up, obtaining an identification of leminorella sp.93.14% on two panels, and shigella sp.99.30% on the other two panels.The customer indicated that biochemical and minimum inhibitory concentration (mic) panel qc were within specification before and after the reported misidentification.The correct identification of the isolate was shigella boydii per 2015 (b)(6) bacteriology participant summary report.There was no patient involved as this was a proficiency survey.

Manufacturer Narrative

The manufacturer participated in the same proficiency survey using (b)(6).When tested on conventional overnight panels and read on the wa instrument, an id of leminorella sp.93.14% was attained.When the same panel was read on the autoscan-4 (as-4) instrument, an id of shigella sp.99.30% was attained.The difference between the two reads was the cf8 (cephalothin 8 (ug/ml) well; the cf8 well was negative on the wa and positive on the as-4.It was noted that the cf8 well was a weak positive when visually verified.The results from the cf8 panel along with the panel results from the other biochemicals/antimicrobics are used to generate the biotype number for the organism tested and the corresponding identification.An id of shigella was also attained on two additional tests using rapid negative panels.Also, the sample was tested on an analytical profile index (api) strip as a reference test method and a low probability id of shigella sp.Was attained.It is possible that emerging resistance with this organism may be contributing to the identification discrepancy.Please refer to medwatch report number 2919016-2015-00045 for report of a similar event.(b)(4).

• Brand Name: NEG BREAKPOINT COMBO 47
• 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 ; 9163742189
• MDR Report Key: 4775092
• MDR Text Key: 16184706
• Report Number: 2919016-2015-00044
• Device Sequence Number: 1
• Product Code: LRG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Model Number: N/A
• Device Catalogue Number: B1017-417
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1