MAUDE Adverse Event Report: PREVI COLOR GRAM INSTRUMENT VERSION 2; PREVI COLOR GRAM INSTRUMENT V2

Model Number	414292
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Intended use: the previ¿ color gram has been designed to perform automated gram staining of pure strain isolate smears and human specimens with microorganisms for in-vitro diagnostics.Description of the issue: a customer in (b)(6) notified biom¿rieux of obtaining incorrect gram stain results when using the previ¿ color gram (reference 414292, serial number # (b)(4)).The customer reported gram negative bacteria is staining blue instead of red colonies.A biom¿rieux internal investigation will be initiated.
Additional Manufacturer Narrative
A customer in sweden notified biomérieux of obtaining incorrect gram stain results when using the previ® color gram (reference (b)(4) serial number (b)(4).Investigation: the investigator reviewed historical complaints and the device history record.There are no capas, nor non-conformities on vitek ms linked with customer complaint.On 07 dec21, local customer service (lcs) informed us that the customer canceled the return of previ color serial number sn (b)(6).During troubleshooting and preliminary investigation activities, there was no indication that the instrument was not performing as intended.It was not possible to define if there was an issue with this instrument since the instrument was not returned; therefore no additional investigation is possible for this case.In addition, the customer did not want to collaborate further to perform additional troubleshooting.On 20 dec 2021, lcs installed the instrument related to this investigation at another customer site, and the instrument functions as expected at this new customer site.This suggests user error at ¿norrlands university hospital¿ with their ¿manipulation¿ and/or ¿workflow¿.Conclusion: biomérieux complaints laboratory was unable to confirm or reproduce the customer¿s issue.Further investigation cannot be conducted without return of the device.

• Brand Name: PREVI COLOR GRAM INSTRUMENT VERSION 2
• Common Device Name: PREVI COLOR GRAM INSTRUMENT V2
• Manufacturer Contact: jeff scanlan ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 12211636
• Report Number: 8020790-2021-00170
• Device Sequence Number: 3839361
• Product Code: KPA
• UDI-Device Identifier: 03573026415310
• UDI-Public: 03573026415310
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: C1 EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2022

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
• Device Catalogue Number: 414292
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2021
• Supplement Date Received by Manufacturer: 01/07/2022
• Initial Report FDA Received Date: 07/22/2021
• Supplement Report FDA Received Date: 01/28/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown