MAUDE Adverse Event Report: BECKMAN COULTER POS COMBO PANEL TYPE 33; MICRO DILUTION PANEL

Model Number N/A

Device Problem False Positive Result (1227)

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

Event Date 11/02/2015

Event Type  malfunction  

Manufacturer Narrative

The data provided by the customer was reviewed and confirmed the high probability misidentification of s.Aureus as s.Intermedius.There was no indication of instrument issues and raw data and processed values for control and growth wells were satisfactory.Pyr values were confirmed as positive on the processed panel reports.Pos combo 33 panel, lot 2016-05-04 is subject to a beckman coulter field action due to falsely negative results for voges-proskauer with quality control american type culture collection organism staphylococcus aureus atcc 29213.(b)(4).

Event Description

It was reported that pos combo 33 panel, lot 2016-05-04 resulted to high probability misidentification of staphylococcus aureus as s.Intermedius.The pyrrolidonyl-b-naphthylamide (pyr) resulted in positive, however the pyr panel well reaction should have been negative, according to the customer's alternate method.Visual verification of the pyr panel well confirmed the positive result.The isolate was not sent to a reference laboratory for confirmatory testing, rather the reported isolate misidentification was based on the customer's alternate method i.E.Latex agglutination test.There were no erroneous results reported out of the laboratory.

Manufacturer Narrative

Beckman coulter issued a field action fa-26321 and an urgent medical device recall letter was sent via (b)(4) to the affected customers on 12/04/2015.The urgent medical device recall letter informs customers that falsely negative result was traced to a single voges-proskauer (vp) component lot used in the manufacturing of the microscan pos combo panel type 33 lot 2016-05-04.The customers were advised to discontinue use and discard any remaining inventory of the affected lot.The vp component which resulted in out of specification results with quality control staphylococcus aureus atcc 29213 is no longer in use.(b)(4).

• Brand Name: POS COMBO PANEL TYPE 33
• 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: 5258304
• MDR Text Key: 32585763
• Report Number: 2919016-2015-00112
• Device Sequence Number: 1
• Product Code: JWY
• 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 faci
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 11/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Expiration Date: 05/04/2016
• Device Model Number: N/A
• Device Catalogue Number: B1017-211
• Device Lot Number: 2016-05-04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: 2050012-12/02/2015-009C
• Patient Sequence Number: 1