MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 AST-P631 TEST KIT

Model Number 414961

Device Problem False Negative Result (1225)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

A customer in (b)(6) notified biomérieux of discrepant results associated with vitek® 2 ast-p631 test kit (reference 414961).The customer reported that the vitek®2 reported a false negative result for (b)(6).The sample was a blood culture, and the test was performed twice on the vitek® 2.Additional testing was conducted on the plp2a test from alere and the test detected (b)(6) both test times.Pcr from cepheid performed directly from the blood bottle also identified (b)(6).There is no indication or report from the laboratory or physician that the discrepant result led to any adverse event related to a patient's state of health.An internal biomérieux investigation will be initiated.

Manufacturer Narrative

A customer in (b)(6) notified biomérieux of a false negative result for msra associated with vitek® 2 ast-p631 test kit (reference 414961).The customer submitted the strain and cards for evaluation.An investigation was performed.The investigation was initiated due to a false susceptible oxacillin (oxa) and false negative cefoxitin screen test (oxsf) on ast-p631 card, which lead to a non-detection of (b)(6) strain on vt2 v7.01.The pcr meca (b)(6) confirmed the presence of a (b)(6) strain.The reference method (agar dilution) gave a susceptible result (0.5mg/l s).Vitek® 2 ast-p631 cards (customer lot, cl 7310221103 and random lot, rl 731398312) were tested and gave an oxa mic = 0.5 mg/l s, an oxsf test negative and a "wild" phenotype.The customer results were duplicated in-house.The oxa vitek® 2 results are in essential agreement when comparing to the reference result (oxa ref mic = 0.5mg/l s).The oxsf test negative is in essential agreement error comparing to the reference method (resistant result on cefoxitin kirby-bauer).In conclusion, there is a presence of a mrsa strain with a low level of resistance, not detected on vitek® 2.The isolate exhibits atypical growth behavior.The vitek® 2ast-p631 cards performed as intended.

• Brand Name: VITEK® 2 AST-P631 TEST KIT
• Type of Device: VITEK® 2 AST-P631 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; saint louis, MO 63042
• MDR Report Key: 6631951
• MDR Text Key: 77559495
• Report Number: 1950204-2017-00189
• Device Sequence Number: 1
• Product Code: LON
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: N50510: S118
• 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: 09/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/05/2018
• Device Model Number: 414961
• Device Lot Number: 7310221103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1