MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 GRAM-POSITIVE IDENTIFICATION ID TEST KIT; VITEK® 2 GP ID TEST CARD

Catalog Number 21342

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

A customer from the united states reported to biomérieux an identification issue in association with the vitek® 2 gp test kit.The customer reported having misidentifications of staphylococcus epidermidis.The customer stated the organism is a coagulase negative staphylococcus and mostly staphylococcus epidermidis.The vitek® 2 gp id test results indicated multiple coagulase negative staphylococcus species.The expected result was staphylococcus epidermidis.The customer tested the samples using a microscan instrument and the results were staphylococcus epidermidis.The customer stated that there was a delay in reporting results when samples are run on microscan, as this testing takes two (2) days to complete.There is no indication or report from the hospital or treating physician to biomérieux that the discrepant results led to any adverse event related to a patient's state of health.The test reports and isolates were requested from the customer.An internal biomérieux investigation has been initiated.

Manufacturer Narrative

A customer from the united states reported to biomérieux an identification issues with staphylococcus epidermidis in association with the vitek® 2 gp test kit.An investigation was conducted.The customer submitted four (4) strains and gp cards from the lot in question, along with gp cards from a different lot that was performing as expected.All four (4) strains were tested on the two card lots returned from the customer, retained cards of the same two lots returned, and one random lot.Therefore, a total of five (5) cards were tested per isolate.Api staph was also performed.Isolate 911279 (40197056039): four of the cards tested gave low discrimination calls of s.Epidermidis / s.Hominis ssp hominis.The fifth card gave an excellent id (97%) of s.Epidermidis.Api staph also gave a good id (94.3%) of s.Epidermidis.Therefore, the final identification is s.Epidermidis.Since the low discrimination call includes the correct call of s.Epidermidis, all cards are performing as expected.Isolate 911280 (40196905288): on all 5 cards tested, a very good id (95%) of s.Epidermidis was obtained.Api staph gave a very good id to the genus of staphylococcus: s.Epidermidis (88.5%) / s.Capitis (7%) /s.Haemolyticus (2%) / s.Hominis (2%).Isolate 911281 (40197163130): four of the cards tested gave very good (94%) or excellent (96%) id of s.Warneri.One card gave a low discrimination call of s.Warneri/s.Epidermidis/s.Hominis ssp hominis.Api staph gave a good id (94%) of s.Warneri.Therefore, the final identification is s.Warneri.Since the low discrimination call includes the correct call of s.Warneri, all cards are performing as expected.Isolate 911286 (40196960368): four of the cards tested gave an excellent id (99%) of s.Epidermidis.One card gave a low discrimination call of s.Epidermidis / s.Hominis ssp hominis.Api staph also gave a good id (90.2%) of s.Epidermidis.Therefore, the final identification is s.Epidermidis.Since the low discrimination call includes the correct call of s.Epidermidis, all cards are performing as expected.A comparison of customer reaction results for the cards giving the misidentification of s.Lugdunensis against expected reaction results for s.Epidermidis revealed one (1) atypical negative reaction (ure).A comparison of customer reaction results for the cards giving the misidentification of s.Hominis ssp hominis against expected reaction results for s.Epidermidis revealed four (4) atypical negative reactions (adh1, dmal, baci, o192r).The investigation concluded the vitek® 2 gp cards are performing as expected and no further action is necessary.

• Brand Name: VITEK® 2 GRAM-POSITIVE IDENTIFICATION ID TEST KIT
• Type of Device: VITEK® 2 GP ID TEST 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; st. louis, MO 63042 ; 3147317301
• MDR Report Key: 6296044
• MDR Text Key: 66361541
• Report Number: 1950204-2017-00041
• Device Sequence Number: 1
• Product Code: LQL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K952095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/20/2017
• Device Catalogue Number: 21342
• Device Lot Number: 2420024103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2016
• 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