MAUDE Adverse Event Report: BIOMERIEUX INC. VITEK® 2 GRAM POSITIVE ID TEST KIT; VITEK® 2 GP ID TEST KIT

Catalog Number	21342
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer from (b)(6) notified biomérieux of a misidentification result when testing an atcc staphylococcus pneumococcus strain (atcc 46619) with the vitek® 2 gp id test kit (ref 21342).Vitek 2 identified the strain as staphylococcus salivarius ssp salivarius.This result was obtained when testing the strain in patient mode rather than qc mode.The strain was also confirmed as streptococcus pneumoniae via vitek ms.As there is no patient associated with this quality control strain, there is no adverse event related to any patient's state of health.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
The initial report stated: a customer from (b)(6) notified biomérieux of a misidentification result when testing an atcc staphylococcus pneumococcus strain (atcc 46619) with the vitek® 2 gp id test kit (ref 21342).Corrected data: the statement should have read "a customer from france notified biomérieux of a misidentification result when testing an atcc streptococcus pneumoniae strain (atcc 49619) with the vitek® 2 gp id test kit (ref 21342).".
Additional Manufacturer Narrative
An investigation was performed for a customer from (b)(6) who reported a misidentification result when testing an atcc streptococcus pneumoniae strain (atcc 49619) with the vitek® 2 gp id test kit (ref 21342).T he customer stated the vitek 2 identified the strain as streptococcus salivarius ssp salivarius.This result was obtained when testing the strain in patient mode rather than qc mode.The strain was also confirmed as streptococcus pneumoniae via vitek ms.The customer did not submit lab reports or the strain for evaluation.The internal biomérieux qc strain was subcultured from a -70° frozen stock to remel tsab agar, incubated at 35-37° c in co2 atmosphere for 18-24 hours.A second subculture was performed and testing included individual organism suspensions with gp cards from the customer's lot (2420528103) and from a random lot (2420587103), in duplicate.The four gp cards tested all gave the expected identification of s.Pneumoniae.No qc deviations or misidentifications were observed.The vitek 2 gp cards performed as expected for this strain.Without the customer's qc strain, lab reports or data submittal it is not possible to further determine the cause of the reported misidentification.

• Brand Name: VITEK® 2 GRAM POSITIVE ID TEST KIT
• Common Device Name: VITEK® 2 GP ID TEST KIT
• Manufacturer (Section D): BIOMERIEUX INC.; 595 anglum road; saint louis MO 63042
• MDR Report Key: 7764477
• Report Number: 1950204-2018-00282
• Device Sequence Number: 1230883
• Product Code: LQL
• UDI-Device Identifier: 03573026131920
• UDI-Public: 03573026131920
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: C1 EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/08/2018
• Device Catalogue Number: 21342
• Device Lot Number: 2420528103
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2018
• Supplement Date Received by Manufacturer: 08/09/2018; 09/18/2018
• Initial Report FDA Received Date: 08/08/2018
• Supplement Report FDA Received Date: 08/09/2018; 10/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1