MAUDE Adverse Event Report: BIOMERIEUX SA PREVI COLOR GRAM V1 - 29551

Catalog Number 29551

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Type  malfunction  

Manufacturer Narrative

Device was not returned to the manufacturer.

Event Description

A customer from united states notified biomérieux of obtaining false gram negative results when testing blood cultures from three separate patients using the previ® color gram v1 (ref.29551, serial (b)(4)).The customer stated the previ® color provided gram negative results for the three patient samples.The isolates were identified and all found to be gram positive organisms.Although the customer stated a false gram negative result was reported to the treating physician, there is no indication or report from the laboratory that the discrepant results led to any adverse event related to any patient's state of health.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

This report was initially submitted regarding a false negative gram stain result in association with the previ® color gram v1 instrument (ref.(b)(4), serial (b)(4)).In response to the customer complaint, biomérieux conducted an internal investigation.The investigation included a staining result analysis and an instrument system analysis using data provided from the customer.Staining result analysis: - sample identification: bacillus sp - gram positive.The initial gram stain was tested using sample taken directly from the blood culture bottle.The sample obtained a result gram negative rods.The blood culture bottle was subcultured; the gram stain using subcultured isolates obtained a result of gram-positive rods.Note: the patients were receiving antimicrobial therapy at the time of blood culture collection.The previ® color gram v1 ifu states antibiotic treatment may render gram-positive bacteria more susceptible to decolorizaion.¿cultures from liquid media also do not adhere to the glass slides as well as cultures taken from isolated colonies.System analysis : the customer did not load a full carousel and did not use ¿blocking slides.¿ use of blocking slides is directed in the previ® color gram service manual to assist in correct staining.The qc and staining tests performed obtained passing results.Conclusion: root cause could not be determined as the instrument and samples were not submitted.The investigation concluded the specimen type, antibiotic therapy, and partial carousel use without blocking slides contributed to the false negative result.The previ® color gram v1 instrument is functioning as intended.See section h11.

• Brand Name: PREVI COLOR GRAM V1 - 29551
• Type of Device: PREVI COLOR GRAM V1 - 29551
• Manufacturer (Section D): BIOMERIEUX SA; chemin de l orme; marcy l etoile 69280 ; FR 69280
• MDR Report Key: 9415594
• MDR Text Key: 219776279
• Report Number: 8020790-2019-00070
• Device Sequence Number: 1
• Product Code: KPA
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 29551
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1