MAUDE Adverse Event Report: BIOMERIEUX, INC PREVI® ISOLA

Catalog Number 29500

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A customer notified biomerieux of a discrepant result using previ isola (reference 29500/lot as180-00306).The customer reported using the previ isola to inoculate four (4) plates cps/pvx/can/can2 for a vaginal sample; however, there was no growth on the plates because the plates were not inoculated.Per archive records, the laboratory identification for this sample was confirmed as being processed by the previ isola with no reported errors.Quality control was performed on 02mar2016 and reported to be ok.Gram stain indicated the presence of a lot of bacteria and vaginosis.The sample was re-plated manually and the result was compatible with vaginosis.Erroneous results were not reported to a physician; however, the diagnosis was delayed by 24 hours.

Manufacturer Narrative

This investigation was initiated in response to a customer in (b)(6) who reported the previ® isola failed to dispense sample onto any of the four (4) plates in the plate panel; however, no error code was produced/displayed by the instrument.One (1) sample (sample id (b)(6)) was affected.Photographs of the unstreaked plates were not received for this investigation.Results of the internal investigation are as follows: the smart pipettor data log from the customer system was received and analyzed.The log showed no evidence that the instrument malfunctioned or that there were any issues with the sample being dispensed on any of the plates in the plate panel.It is concluded from the log data that the sample present in test panel pvn, sample id (b)(4), processing in rack 1, position 10 with tip #40 was correctly deposited onto each of the four (4) plates in the panel.The instrument pressure parameters gave indications that there were no malfunction or errors in the dispense process.Given a four (4) plate panel (three (3) independent pipettor tip pressure tests per each of the four plates tested in the plate panel sample) without a single anomalous value, it is extremely unlikely that the system did not dispense onto any one of the plates, without an error.In addition to the 12 separate pressure evaluations by the system's algorithms, the initial tip pressure evaluation and the final test for sample remaining (blowout test) showed no errors.The complaint cannot be confirmed by the pressure data.In conclusion, biomérieux was unable to confirm the customer's reported complaint.

• Brand Name: PREVI® ISOLA
• Type of Device: PREVI® ISOLA
• 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: ryan lemelle ; 595 anglum road; hazelwood, MO 63042 ; 3147318582
• MDR Report Key: 5579120
• MDR Text Key: 43466792
• Report Number: 1950204-2016-00048
• Device Sequence Number: 1
• Product Code: LXG
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• 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: 03/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 29500
• Device Lot Number: AS180-00306
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2016
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1