MAUDE Adverse Event Report: BIOMERIEUX S.A. CHROMID® CPS ELITE; CHROMID CPS ELITE 100 PL TRANS - 416172

Model Number	416172
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in (b)(6) notified biomérieux of no/low growth on chromid® cps elite 100 pl trans (ref 416172 lot 1007755860) for a patient urine specimen.The customer reported that the sample from the patient was tested in parallel on the chromid® cps agar and blood agar.The customer could observe many colonies on the blood agar and very few or none on the chrmid® cps agar.The customer also observed that the chromid® cps agar plate area was not flat and homogenous.There is no indication or report from the laboratory that this event led to any adverse event related to the patient's state of health.
Additional Manufacturer Narrative
An investigation was initiated in response to a customer complaint of no/low growth on chromid® cps elite 100 pl trans (ref 416172 lot 1007755860) for a patient urine specimen.The customer also observed that the chromid® cps agar plate area was not flat and homogenous.The customer indicated that there were no more plates available at their site to send back for investigation purposes.The internal investigation was performed through batch record analysis and evaluation of retention samples from the lot used by the customer (lot 1007755860).All qc tests for lot 1007755860 were within specification.Thickness and flatness of agar are process controls only for media that are used with susceptibility testing.Since the chromid cps elite agar is not intended for use with susceptibility testing, there are no established specifications for agar thickness and flatness, but a visual examination is performed.Visual examinations and measurements with calipers were performed on retention samples from lot 1007755860 and another lot produced near the same time frame, as a reference.The measurements with calipers showed slight differences in agar thickness for both lots (from quadrant to quadrant), however, these differences were not able to be detected by visual examination alone.Maximum difference for customer's lot: 0.32 mm.Maximum difference for reference lot: 0.26 mm.There have been no other customer complaints registered for lot 1007755860.The investigation concluded that the customer's lot (lot 1007755860) meets specifications.Without submission of the actual plates from the customer, no root cause can be established for the issues reported by the customer.See h10 for addtl mfg narrative.

• Brand Name: CHROMID® CPS ELITE
• Common Device Name: CHROMID CPS ELITE 100 PL TRANS - 416172
• Manufacturer (Section D): BIOMERIEUX S.A.; 5 rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 9787644
• Report Number: 9615755-2020-00002
• Device Sequence Number: 2650341
• Product Code: JXA
• UDI-Device Identifier: 03573026443900
• UDI-Public: 03573026443900
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: C1 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): 03/27/2020

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 Expiration Date: 03/29/2020
• Device Model Number: 416172
• Device Lot Number: 1007755860
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2020
• Supplement Date Received by Manufacturer: 03/09/2020
• Initial Report FDA Received Date: 03/04/2020
• Supplement Report FDA Received Date: 03/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1