MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 ANC ID TEST KIT

Catalog Number 21347

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

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

A customer in (b)(6) contacted biomérieux to report a misidentification of atcc baa 1296 bacteroides ovatus as fusobacterium mortiferum in association with the vitek 2 anaerobic and corynebacteria (anc) identification (id) test kit.The customer also tested a replacement atcc baa 1296 bacteroides ovatus strain and obtained incorrect results.The customer obtained a new frozen cryobead strain; testing via vitek 2 anc id card achieved the expected result of bacteroides ovatus.The customer stated they have a mass spectrometer, and the discrepant vitek 2 anc id results had no adverse impact to any patient's state of health.The atcc baa 1296 bacteroides ovatus strain was not directly related to any patient.Biomérieux investigation will be initiated.

Manufacturer Narrative

A customer in (b)(6) contacted biomérieux to report a misidentification of atcc® baa 1296¿ bacteroides ovatus as fusobacterium mortiferum in association with the vitek® 2 anaerobic and corynebacteria (anc) identification (id) test kit.A biomérieux internal investigation was performed.The customer reported using all required set ups for anc qc testing; however, their original strain was stored at -24c when storage at -70c is recommended.A strain was obtained from another source and tested from the appropriate medium; however, a 48-hour culture was used when the age of culture should be 18-24 hrs.The strain was unidentified.The strain was then obtained from a new frozen cryobead and correct results were obtained.Eight (8) lab reports were submitted.Results are listed by date of testing.On (b)(6) 2016: unidentified organism with six (6) incorrect qc reactions (5/6 were expected positives reporting as negative).On (b)(6) 2016: unidentified organism with five (5) incorrect qc reactions (5/5 were expected positives reporting as negative).On (b)(6) 2016 (#1): fusobacterium mortiferum with six (6) incorrect qc reactions (6/6 were expected positives reporting as negative).On (b)(6) 2016 (#2): unidentified organism with five (5) incorrect qc reactions (5/5 were expected positives reporting as negative).On (b)(6) 2016: unidentified organism with 14 incorrect qc reactions (10/14 were expected positives reporting as negative).On (b)(6) 2016: bacteroides ovatus with three (3) incorrect qc reactions (3/3 were expected positives reporting as negative).On (b)(6) 2016: low discrimination result with bacteroides ovatus and 13 incorrect qc reactions (13/13 were expected positives reporting as negative).On (b)(6) 2016: bacteroides ovatus with all qc reactions correct.An increased number of atypical negative results can indicate a strain with decreased viability or user set up error, improper storage of the strain or environmental conditions were not sufficient to properly grow this anaerobic qc strain.Without the strain or raw data it's not possible to further evaluate the cause of the mis-identification.On 11nov2016 industrialization-anc lot 244386840 and 244394540 met final qc release criteria.There were no issues observed on initial qc performance testing.No further action deemed necessary.

• Brand Name: VITEK® 2 ANC ID TEST KIT
• Type of Device: VITEK® 2 ANC ID 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: 6083972
• MDR Text Key: 59348920
• Report Number: 1950204-2016-00167
• Device Sequence Number: 1
• Product Code: JSP
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K910666
• 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: 10/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 07/17/2017
• Device Catalogue Number: 21347
• Device Lot Number: 244386840
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2016
• 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