MAUDE Adverse Event Report: BIOMERIEUX, SA NUCLISENS® LYSIS BUFFER

Catalog Number 200292

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

A customer in (b)(6) notified biomérieux that they obtained colored eluates and inhibited results when extracting whole blood samples with nuclisens® lysis buffer (ref.200292, lot 19040201).The customer reported that some eluates were colored and that inhibition was visible at the level of amplification for eight (8) samples.These samples were tested for detection of adenovirus and (b)(6).For one (1) sample, the extractions were repeated twice with the same lot: no amplification was found for internal control 2.The customer repeated extraction with another batch of nuclisens lysis buffer (lot 19032602) and results were not inhibited.The customer reported that four (4) to 11 days were necessary for rendering results.The customer is typically able to report results in three (3) days.There is no indication or report from the laboratory that the delayed results led to any adverse event related to the patient's state of health.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

An internal investigation was performed for a french customer complaint of obtaining colored eluates and inhibited results when extracting whole blood samples with nuclisens® lysis buffer (ref.200292, lot 19040201).A previous investigation confirmed that the eluates become colored because of remaining hemoglobin originating from the samples containing blood.It also confirmed that the presence of hemoglobin can cause the inhibition of downstream applications (pcr, rt pcr, nasba etc.).In most cases, the test result is uninterpretable as the internal control would also be inhibited, invalidating the test.The current investigation highlighted that the root cause of the coloration is due to a non-conform ph value of lysis buffer lot 19040201, which is a result of a ph-meter dysfunction.This ph-meter dysfunction is linked to a failure in the ph electrode, which was not detected via daily calibration/verification.The investigation team performed analytical and functional tests on impacted batch 19040201 and did confirm the customer's issue.The same tests were also performed on all reagents manufactured with the non-conform ph-meter, and results showed that there is no other reagent impacted by the ph-meter dysfunction.It should be noted that the previous investigation confirmed that the colored eluates occurrence is increased by poor whole blood sample quality.Also to be noted, colored eluates only occur on whole blood samples or other specimens containing blood, such as dry blood spots and stools (not on all claimed matrix), because of remaining hemoglobin in the eluate.Samples with no hemoglobin are not impacted by this issue and can be used with the lysis buffer lot 19040201 with expected performance.As corrective action, the defective electrode has been replaced on the impacted ph-meter, and the ph-meter calibration/verification process will be reviewed and improved to detect earlier any drift of ph-meter used in manufacturing.In addition, since may 2019, a limitation informing our customers not to use colored eluates has been added in our instructions for use n°043969-03 (for nuclisens accessory products) and n°050874-01 (for nuclisens magnetic extraction reagents), which are to be used in combination with lysis buffer 2ml ref 200292.Additionally, "fsca 4613 - nuclisens® lysis buffer (ref.200292, lot 19040201) - colored eluates" was issued to notify customers who received this batch about the issue and the actions to be taken.

• Brand Name: NUCLISENS® LYSIS BUFFER
• Type of Device: NUCLISENS® LYSIS BUFFER
• Manufacturer (Section D): BIOMERIEUX, SA; 5 rue des berges; 38024 grenoble, ; FR
• MDR Report Key: 9240568
• MDR Text Key: 208595200
• Report Number: 3008249922-2019-00005
• Device Sequence Number: 1
• Product Code: PPM
• Combination Product (y/n): N
• PMA/PMN Number: C1 EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 200292
• Device Lot Number: 19040201
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/25/2019
• Initial Date FDA Received: 10/25/2019
• Supplement Dates Manufacturer Received: 02/03/2020
• Supplement Dates FDA Received: 03/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: FSCA 4613
• Patient Sequence Number: 1
• Patient Outcome(s): Disability