MAUDE Adverse Event Report: BIOMÉRIEUX, INC. DENSICHEK PLUS; DENSICHEK® PLUS

Model Number	21250
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in (b)(6) notified biomérieux of obtaining a fluctuation in the turbidity reading while using the densicheck ® plus instrument (reference # 21250, serial # (b)(4)).The turbidity (optical density) is expressed in units of mcfarlands (mcf).This issue occurred while the customer performed maintenance instrument verification; therefore, there was no patient involvement.The customer has been using this instrument since 2014.They were performing maintenance instrument verification with a standard kit that was within expiry when they noticed the read value fluctuating.A field service expert (fse) went to the customer site to change the batteries in the instrument, perform cleaning of the tube insert and replace the standard kit with a new one but the issue still occurred.It was recommended that the customer replace their existing instrument.Densichek® plus is intended for use with the vitek® and vitek® 2 systems to measure the optical density of a microorganism suspension.This microorganism suspension is then analyzed with the vitek® or vitek® 2 instruments.The required mcf values for microorganism suspensions are specified in the culture requirements table for vitek® 2 reagents.Too low or too high mcf values while preparing isolates from patient samples can result in false susceptible or false resistant results respectively.A biomérieux internal investigation has been initiated.
Additional Manufacturer Narrative
This report was initially submitted following notification from a customer in (b)(6) regarding a fluctuation in the turbidity reading while using the densicheck® plus instrument (reference # 21250, serial # (b)(4)).The turbidity (optical density) is expressed in units of mcfarlands (mcf).The customer reported this event to the (b)(6) national medical products administration (nmpa).The device was not returned for evaluation as the customer is currently utilizing the densichek plus instrument.The customer¿s case report states: ¿for the densichek plus instrument, the concerning unit is installed at (b)(6), 2014, with serial no.As (b)(4), we use a box of standard kit within expiry limit to perform verification with refer to standard operation procedure by vortex the tube, set the material to glass, load the bottle and perform reading, but we find the read value fluctuates and make the test result unreliable.¿ it was determined that vortex mixing of the standards was the root cause.Vortex mixing is considered off-label use, as a vortex mixer is similar to shaking the standards.The densichek® plus instrument user manual (pn 24384) & the 21255 standard package insert (pn 043395) states ¿2.Gently invert the 0.0 mcf standard five to six times to ensure it is homogeneous¿ and ¿5.0 gently invert the standard five to six times to ensure it is homogeneous¿.The caution/warnings and precaution states ¿do not shake the standard.Air bubbles will affect readings¿.

• Brand Name: DENSICHEK PLUS
• Common Device Name: DENSICHEK® PLUS
• Manufacturer (Section D): BIOMÉRIEUX, INC.; 595 anglum road; hazelwood MO 63042
• MDR Report Key: 11041589
• Report Number: 1950204-2020-00217
• Device Sequence Number: 19091152
• Product Code: LON
• UDI-Device Identifier: 03573026222239
• UDI-Public: 03573026222239
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K083536
• 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): 03/22/2021

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: 21250
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2020
• Supplement Date Received by Manufacturer: 03/01/2021
• Initial Report FDA Received Date: 12/18/2020
• Supplement Report FDA Received Date: 03/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1