MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK 2 ANC TEST KIT; VITEK 2 ANC CARD

Catalog Number 21347

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

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

A customer in (b)(6) notified biomérieux of a misidentification associated with vitek® 2 anc test kit involving an external quality control sample ((b)(6)).The customer obtained a result of atopobium vaginae instead of propionibacterium acnes using the vitek® 2 anc card.Four (4) identifications were performed with the same result.An internal biomérieux investigation will be initiated.

Manufacturer Narrative

A second supplementary medwatch report is being submitted because fields b.4 and g.4 were erroneously omitted on the first supplement.

Manufacturer Narrative

An internal biomérieux investigation was performed with results as follows: · vitek® 2 anc test kit (lot 244390210): provided organism identification to the species propionibacterium acnes, as expected.· sequencing: provided organism identification to the species propionibacterium acnes, as expected.· vitek® ms: provided organism identification to the species propionibacterium acnes, as expected.· api® 20a: provided organism identification to the species propionibacterium acnes, as expected.· rapid id32a: inacceptable profile.· api® cotyne: doubtful profile.The investigation concluded the vitek® 2 anc test kit is performing as intended.

• Brand Name: VITEK 2 ANC TEST KIT
• Type of Device: VITEK 2 ANC CARD
• 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: 6109073
• MDR Text Key: 60431413
• Report Number: 1950204-2016-00184
• 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,Followup
• Report Date: 02/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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: 01/20/2017
• 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