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

Catalog Number 21342

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Type  malfunction  

Event Description

A customer from (b)(6) notified biomerieux of misidentification results for a cadaver sample when testing with vitek 2 gp id test kit ( reference (b)(4).The customer stated that vitek 2 gave a low discrimination result: kocuria or alloiococcus otitis.The customer stated the organism is streptococcus pneumoniae.For this identification of streptococcus pneumoniae, neither the confirmatory testing method(s) used nor the results have been provided by the customer yet.As this was a cadaver strain, there was no effect on any patient treatment or condition.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.An internal biomerieux investigation will be conducted.

Manufacturer Narrative

The issue was initially reported after a customer from (b)(64) notified biomérieux of misidentification results for a cadaver sample when testing with vitek® 2 gp id test kit ( reference 21342).The customer stated that vitek 2 gave a low discrimination result: kocuria or alloiococcus otitis.The customer stated the organism is streptococcus pneumoniae.On 19mar2018, biomérieux received lab reports from the customer providing new information that this case did not involve a cadaver sample, rather a quality control (qc) organism.The customer confirmed this potential misidentification was for the streptococcus pneumonia qc strain, atcc 49619.The lab reports showed that there were several negative reactions for the test kit, which can indicate that the strain has lost viability.It was also noted that the original media used in this misidentification is non-validated media.The customer was asked to retest using a fresh strain from validated media.As of the date of this report, the customer has not responded with any retest results.An internal biomérieux investigation is in progress.

Manufacturer Narrative

An internal biomérieux investigation was performed due to a customer from (b)(6) who notified biomérieux of a misidentification result in association with vitek® 2 gp card, lot 2420460203 when testing streptococcus pneumoniae atcc 49619.The vitek2 gp card resulted in atypical negative appa, draf, and sal reactions leading to a misidentification as kocuria rosea.The customer's strain was not submitted for investigation.The internal biomérieux streptococcus pneumoniae atcc 49619 qc strain was subcultured to remel tsab media and testing included individual organism suspensions with vitek 2 gp cards from the customer's lot (2420460203) and from a random lot (2420462403), in duplicate.The four (4) vitek 2 gp cards all gave the expected positive appa, draf, and sal reactions.No qc deviations or misidentifications were observed.Vitek 2 gp cards performed as expected for this strain.Without the customer's qc strain or data submittal, it is not possible to further determine the cause of the reported misidentification.Vitek 2 gp test kit lot #2420460203 met final qc release criteria and passed initial qc performance testing.

• Brand Name: VITEK® 2 GRAM POSITIVE ID TEST KIT
• Type of Device: VITEK® 2 GP ID TEST KIT
• Manufacturer (Section D): BIOMERIEUX INC.; 595 anglum road; saint louis MO 63042
• Manufacturer (Section G): BIOMERIEUX INC.; 595 anglum road; saint louis MO 63042
• Manufacturer Contact: ellen weltmer ; 595 anglum road; hazelwood, MO 63042 ; 3147317301
• MDR Report Key: 7327523
• MDR Text Key: 102102672
• Report Number: 1950204-2018-00096
• Device Sequence Number: 1
• Product Code: LQL
• UDI-Device Identifier: 03573026131920
• UDI-Public: 03573026131920
• Combination Product (y/n): N
• PMA/PMN Number: C1 EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 05/23/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: 21342
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/09/2018
• Initial Date FDA Received: 03/09/2018
• Supplement Dates Manufacturer Received: 03/19/2018; 05/01/2018
• Supplement Dates FDA Received: 04/17/2018; 05/23/2018
• 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