MAUDE Adverse Event Report: BIOMERIEUX SA PREVI¿ COLOR GRAM (VERSION2); PREVI COLOR GRAM INSTRUMENT V2 - 414292

Model Number	414292
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in (b)(6) notified biomérieux of obtaining discrepant staining results in association with the previ¿ color gram instrument v2 (ref.414292, serial number (b)(4)).The customer stated their previ¿ color instrument provided gram positive (purple) stain results for both gram positive and gram negative samples.The customer replaced the reagent pack and but still obtained discrepant gram stain results.Biomérieux customer service determined the previ¿ color instrument performed incomplete staining cycles which resulted in slides remaining purple (gram positive).As the customer concluded that the gram stain results could not be used for interpretation, there is no indication or report from the laboratory that the non- interpretable results led to any adverse event related to the patient's state of health.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
A customer in vietnam notified biomérieux of obtaining discrepant staining results in association with the previ¿ color gram instrument v2 (ref.414292, serial number 414292171567).The customer stated their previ¿ color instrument provided gram-positive (purple) stain results for both gram positive and gram-negative samples.In response to the customer complaint , biomérieux conducted an internal investigation.The investigation included a review of information provided by the customer and review of the device history record.A review of the customer's device logs determined the instrument was set to the default setting with fixation set to normal instead of off.The investigation concluded this would have no effect on the staining cycle.No instrument faults were noted in the logs during the impacted period.The device history record review showed no capa or non-conformity records associated with previ¿ color gram instrument v2 (ref.414292, serial number (b)(6)).The root cause could not be established; however, the evidence suggests a potential cause of the staining discrepancy was due to poor device maintenance.The photographs showed the previ¿ color gram instrument v2 bowl was dirty.Additionally, customer service confirmed the staining issue was resolved after performing volume and pattern tests.

• Brand Name: PREVI¿ COLOR GRAM (VERSION2)
• Common Device Name: PREVI COLOR GRAM INSTRUMENT V2 - 414292
• Manufacturer (Section D): BIOMERIEUX SA; chemin de l orme; marcy l etoile, rhone 69280, ; FR
• MDR Report Key: 9588840
• Report Number: 8020790-2020-00002
• Device Sequence Number: 19751469
• Product Code: KPA
• UDI-Device Identifier: 03573026415310
• UDI-Public: 03573026415310
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: C 1 EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2020

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
• Operator of Device: Health Professional
• Device Model Number: 414292
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2019
• Supplement Date Received by Manufacturer: 02/04/2020
• Initial Report FDA Received Date: 01/14/2020
• Supplement Report FDA Received Date: 03/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1