MAUDE Adverse Event Report: BIOMERIEUX, INC PREVI® ISOLA

Model Number 29500

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

A customer in (b)(6) reported the occurrence of no plate growth (false negative) for a patient urine sample in association with the previ isola.Subsequent manual plate streaking (retest) using the same volume of urine (10¿l) produced gram negative bacilli organism growth.The manual retest was performed and processed prior to reporting any result to the physician; therefore, the previ isola plate behavior had no impact on patient therapy.The customer stated there was no adverse impact to the patient.The customer stated there was a delay of >24 hours in reporting results to the treating physician.The patient's urine specimen is no longer available for investigation.Biomérieux internal investigation will be initiated.

Manufacturer Narrative

A biomérieux internal investigation was performed.This investigation was initiated in response to a customer complaint reporting that plates streaked by previ® isola did not exhibit organism growth following incubation, while plates streaked manually from the same specimens did exhibit growth.A complaint and trend review was performed; no systemic quality issue was identified.The customer's complaint could not be investigated or confirmed due to lack of information or details to investigate.Pipettor logs from the date of occurrence were not received.As of 27mar2017, after multiple requests by biomérieux, no additional information has been received concerning this issue.

• Brand Name: PREVI® ISOLA
• Type of Device: PREVI® ISOLA
• Manufacturer (Section D): BIOMERIEUX, INC; 595 anglum road; st. louis MO 63042
• Manufacturer (Section G): BIOMERIEUX, INC; 595 anglum road; st. louis MO 63042
• Manufacturer Contact: ellen weltmer ; 595 anglum road; st. louis, MO 63042
• MDR Report Key: 6249047
• MDR Text Key: 64777729
• Report Number: 1950204-2017-00017
• Device Sequence Number: 1
• Product Code: LXG
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 29500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1