MAUDE Adverse Event Report: BIOMERIEUX SA PREVI COLOR GRAM INSTRUMENT; PREVI® COLOR GRAM INSTRUMENT

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 incorrect gram stain results in association with previ color gram instrument (reference 414292 serial (b)(4).The customer stated they obtained gram negative results for gram positive organisms.Specifically, the customer obtained an incorrect gram result for a clinical blood culture sample.There is no indication or report from the laboratory that the discrepant result led to any adverse event related to the patient's state of health.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
This report was initially submitted following notification from a customer in ireland regarding incorrect gram stain results in association with previ® color gram instrument (reference(b)(4) serial: (b)(6).A biomérieux internal investigation has been completed with the following results: a trend analysis was completed regarding the complaints recorded for a staining issue.Probability as per safety risk management procedure 001622 rev 06.A: improbable there is no capa, no non conformity on previ color linked with customer 's complaint.The customer's strain was tested.This issue was not reproduced with previ color v1 but was reproduced with previ color v2.The strain was determined to be enterococcus faecalis with the vitek® ms instrument.Since e.Faecalis is a common strain and this is the first instance of this issue the root cause was linked to an atypical strain.

• Brand Name: PREVI COLOR GRAM INSTRUMENT
• Common Device Name: PREVI® COLOR GRAM INSTRUMENT
• Manufacturer (Section D): BIOMERIEUX SA; chemin de l orme; marcy l etoile, rhone 69280, ; FR
• MDR Report Key: 9131177
• Report Number: 8020790-2019-00056
• Device Sequence Number: 336430
• Product Code: KPA
• UDI-Device Identifier: 03573026415310
• UDI-Public: 03573026415310
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: 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): 07/08/2020

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: 08/29/2019
• Supplement Date Received by Manufacturer: 06/11/2020
• Initial Report FDA Received Date: 09/27/2019
• Supplement Report FDA Received Date: 07/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1