MAUDE Adverse Event Report: BIOMERIEUX INC. VITEK®2 AST-P634 TEST KIT

Catalog Number 415671

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem Misdiagnosis (2159)

Event Type  malfunction  

Event Description

A customer from the (b)(6) reported a false susceptible result for a (b)(6) strain associated with vitek®2 ast-p634 test kit 20 cards (lot 7340502403).The customer stated that during the initial testing of the impacted strain from a patient isolate (wound swab: abscess) using cos media from oxoid, they obtained results consistent with a (b)(6) strain.The strain was sent to the (b)(6) reference laboratory for pvl testing, and the result was (b)(6).After discussion with the reference laboratory it was discovered that on their initial vitek®2 testing the isolate appeared to be a (b)(6) strain but after a (b)(6) pcr test for meca gene and further testing (oxacillin mic value=(b)(6) ; cefoxitin mic value = 64 mg/l) the reference laboratory reported (b)(6).Repeat swabs from the same patient were requested two months later, and were cultured on (b)(6) media and routine columbia blood agar from oxoid.The s.Aureus strain isolated from the (b)(6) media when tested on vitek indicated (b)(6).The strain isolated from blood agar plate was tested on vitek and indicated a conflict between cefoxitin and oxacillin.A cefoxitin etest ® was performed with the result of (b)(6).This isolate when tested at the (b)(6) reference lab again and was found to be a (b)(6).The (b)(6) reference laboratory also performed etest for cefoxitin (b)(6) and oxacillin (b)(6).The customer stated that patient results were affected and wrong results reported to the physician that led to an inappropriate treatment by flucloxacillin and that there was a delay in reporting results.The customer stated that at the moment of the first test, the patient was maybe under flucloxacillin treatment , and it was not known if the swab was taken before antibiotic treatment started.The isolate was possibly subjected to various antibiotic treatments prior to vitek®2 testing that could have affected its growth and test results.Biomérieux recommended that the customer repeat testing using columbia agar without antibiotic addition.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

This investigation was initiated due to a customer reporting a discrepant cefoxitin screen test (oxsf) and a discrepant susceptible oxacillin (ox) result for a staphylococcus aureus patient isolate associated with vitek® 2 v7.01 software, ast-p634 card.The presence of an (b)(6) strain was confirmed by pcr meca positive and clonal complex cc5-(b)(6)-iv (pediatric clone).The reference method (agar dilution) for oxacillin (ox) gave resistant (r) results (ox mic = 4 mg/l r).The disc diffusion for cefoxitin (fox) gave : d=16 mm r.Tests performed on vitek 2 v7.01, ast-p634 card (aes parameters : global european based + phenotypic) : three ast-p634 cards (one from customer lot # 7340423203 (cl1), one from customer lot # 7340502403 (cl2) and one from a random lot # 7340690403 (rl)) were tested from cos subculture.Note: coh and brillance (b)(6) media are not recommended by biomerieux to test vt2 cards.- cl and rl: ox mic = 0.5 mg/l s, oxsf negative test with "acquired penicillinase" phenotype.- the vitek 2 ox values are discrepant compared to the reference mic.- the negative oxsf tests are not correlated with the disc diffusion result (fox kb r).Conclusion: * on vitek 2 system version 7.0, false susceptible oxacillin and negative oxsf results were reproduced internally, which lead to the non-detection of the mrsa isolate due to late growth in oxsf well.* the new software version 8.01 improves the detection of the (b)(6) phenotype since oxsf test is obtained (b)(6), and aes system gave "modification of pbp" phenotype (oxsf knowledge base was modified in this new version).

• Brand Name: VITEK®2 AST-P634 TEST KIT
• Type of Device: VITEK®2 AST-P634 TEST KIT
• Manufacturer (Section D): BIOMERIEUX INC.; 595 anglum road; st. louis MO 63042
• Manufacturer (Section G): BIOMERIEUX INC.; 595 anglum road; st. louis MO 63042
• Manufacturer Contact: debra broyles ; 595 anglum road; hazelwood, MO 63042 ; 3147317301
• MDR Report Key: 7537139
• MDR Text Key: 109044519
• Report Number: 1950204-2018-00197
• Device Sequence Number: 1
• Product Code: LON
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K053097
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/23/2019
• Device Catalogue Number: 415671
• Device Lot Number: 7340423203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other