MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 AST-YS07 TEST KIT

Catalog Number 414967

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

A customer in (b)(6) reported the occurrence of false susceptible fluconazole (mic <=1 mg/l) for candida albicans (b)(6) sample in association with the vitek 2 ast-ys07 test kit.Repeat test obtained the same result.As evident from the report from (b)(6), approximately 50% of the laboratories involved in the survey using automated susceptibility testing systems reported the candida albicans strain as susceptible for fluconazole, itraconazole, and voriconazole.There is no indication or report from the laboratory that the discrepant result led to any adverse event related to any patient's state of health.There was no patient directly associated with the survey sample.Culture submittal was requested by biomerieux for internal investigation.Biomerieux investigation will be initiated.

Manufacturer Narrative

A customer in denmark reported the occurrence of false susceptible fluconazole (mic <=1 mg/l) for candida albicans neqas sample in association with the vitek® 2 ast-ys07 test kit.An internal investigation was performed.This investigation was initiated due to discrepant results on three (3) drugs ( amphoterin b, fluconazole, voriconazole)on ast-ys07 card for one isolate candida albicans, from an external quality control called neqas (distribution 3789-strain 2938).Neqas information/expected results: -amphotericin b mic = 0.125mg/l s.-fluconazole mic >6 4 mg/l r.-voriconazole mic >8 mg/l r.Please note: in the final report from neqas, fluconazole and voriconazole were not graded since the "levels of concordance with fluconazole (63%) and voriconazole (59%) did not reach the requisite 80% of participants".Biomérieux performed the reference methods to determine the intended results for amphotericin b (broth macrodiution), and for fluconazole and voriconazole (both microdilution), compared to vitek® 2 ast-ys07 cards.Amphotericin b reference mic= 0.5mg/l s, fluconazole ref mic >64 mg/l r and voriconazole ref mic >16 mg/l r were obtained.On vitek® 2, the following were obtained: -from sda media and on 2 ast-ys07 lots: ab mic =8 r (>=16 r) - flu mic =16 i and vrc mic= 1s.-from cos media and on 1 ast-ys07 lot: ab mic =8 r - flu mic <=1s and vrc mic<=0.125 s.Vitek® 2 amphotericin b results (8 - >=16 mg/l r) are in essential agreement error (gap >2 doubling dilutions with the reference mic) which lead to a major error.Vitek® 2 fluconazole results (<=1 mg/l s) and voriconazole results (<=0.125- 1 mg/l s) are in essential agreement errors (gap >2 doubling dilutions with the reference mic) which lead to a very major error for each drug.Biomérieux duplicated the non-reproducible results and the discrepancies with expected neqas values.The investigation concluded that the isolate exhibits atypical growth behavior.

• Brand Name: VITEK® 2 AST-YS07 TEST KIT
• Type of Device: VITEK® 2 AST-YS07 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: ellen weltmer ; 595 anglum road; hazelwood, MO 63042 ; 3147317301
• MDR Report Key: 6064646
• MDR Text Key: 58824369
• Report Number: 1950204-2016-00160
• Device Sequence Number: 1
• Product Code: NGZ
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K133817
• 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: 02/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 414967
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2016
• 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