MAUDE Adverse Event Report: BIOMERIEUX, SA PREVI® COLOR GRAM

Model Number	414292
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in (b)(6) reported gram staining issues for blood culture samples from two patients (p1, p2), in association with the previ® color gram instrument.The customer stated that blood culture bottles for each patient, were processed with the bact/alert ® instrument and flagged as positive.The cultures were then placed on isolation media and also gram stained.The initial gram stain results were gram negative coccobacilli (p1) and bacilli (p2).After 24 hours there was no growth on the isolation media, so the same bottles had the gram stain repeated, and the results were gram positive coccobacilli (p1) and bacilli (p2).Vitek® ms identified both samples as listeria monocytogenes (gram positive bacilli).The customer reported that when coloring these blood culture samples in the instrument, they were accompanied by other samples in which bacterial morphology was observed adequate for each type of sample and where both gram-positive and gram-negative bacteria are detected.The customer stated the wrong result was reported to the physician but patient treatment was not impacted.The patient's clinical signs did not coincide with the symptoms of a gram-negative microorganism, so the doctor decided to continue with the initial treatment until the final result of the culture.P1 was a (b)(6) female renal patient, and p2 was a newborn patient.There is no indication or report from the hospital or treating physician to biomérieux 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
An internal investigation was done following the report of gram staining issues for blood culture samples from two patients in association with the previ® color gram instrument.The initial gram stain results were gram negative for both patients.Repeat results were gram positive.Vitek® ms identified both samples as listeria monocytogenes (gram positive bacilli).For the investigation, biomérieux requested the following from the customer: pictures of staining and of the instrument; logs from the instrument; qc slides if done; other similar problem before and after this case.Pictures of staining were sent without legend and interpretation.No picture of the instrument was provided; no log sent : however, customer said that the daily, weekly and monthly maintenances were well done; the customer had previously registered a complaint for a staining issue on 05may2017, and troubleshooting determined there to be a problem with cleaning and priming of the instrument; the customer said that when the issue occurred, there was other samples in the previ-color.The results seen were adequate for each type of sample, and both gram-positive and gram-negative were observed.In the following documentation, it is written: "antibiotic treatment may render gram-positive bacteria more susceptible to decolorization." reference: impact of reporting gram stain results from blood culture bottles on the selection of antimicrobial agents - american journal of clinical pathology, volume 132, issue 1, 1 july 2009." conclusion: taking in account all provided information, the investigation did not provide evidence that the misinterpretation was due to the previ color gram system.

• Brand Name: PREVI® COLOR GRAM
• Common Device Name: PREVI® COLOR GRAM
• Manufacturer (Section D): BIOMERIEUX, SA; 3 route de port michaud; la balme, les grottes isere 38390 ; FR 38390
• MDR Report Key: 8116175
• Report Number: 3002769706-2018-00248
• Device Sequence Number: 268701
• Product Code: KPA
• UDI-Device Identifier: 03573026415310
• UDI-Public: 03573026415310
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 02/13/2019

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: 10/30/2018
• Supplement Date Received by Manufacturer: 01/15/2019
• Initial Report FDA Received Date: 11/29/2018
• Supplement Report FDA Received Date: 02/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR