MAUDE Adverse Event Report: BIOMERIEUX S.A. CHROMID® CPS ELITE

Catalog Number 416172

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

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

A customer in the (b)(6) reported a false negative (no growth) result for a neqas survey sample ((b)(6)), when using the chromid® cps elite agar (lot1006666680).The expected result of the neqas sample was staphylococcus saprophyticus.The customer tested a new sample on the same lot of chromid cps elite and on columbia blood agar.The isolate grew well on the columbia blood agar, but had no growth on the chromid cps elite.The customer received a new sample ((b)(6)) from neqas and tested it on the chromid cps elite, and the result was no growth.There was no patient involvement as the event pertained to a survey sample.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

An internal investigation was performed due to a no result (no growth) for an external quality control (eqa) sample (neqas distribution 4341 sample 4569) on chromid® cps elite (cpse) agar.Lot number record analysis: qc records confirmed that lots 1006606560 and 100666680 met all specifications prior to product release, take into consideration that s.Saprophyticus is not tested on a routine bases.Non-conformities and deviations were not recorded on this lot number.Retained sample analysis: in order to check if the medium has still the same performance, two staphylococcus saprophyticus (internal attc 15305 strain and neqas customer strain) were streaked on : one fresh chromid cpse, in order to demonstrate iif along the shelf life of the product the sensitivity could change.Both chromid cpse batches complained ( 1006606560 and 100666680).Two chromid cpse batches with the same expired that than both batches complained plates were incubated at 33-37ºc and incubated up to 20-28 hours.All chromid cpse showed an optimal performance regarding sensitivity for their ability to support the growth of both s.Saprophyticus.The batches met requirements regarding performance specifications, and both strains were able to grow.Complaint trend analysis: a review of complaints registered for both impacted batches 1006666680 and 1006606560 did not indicate any systemic trend.Statistical trend analysis was performed for this product (jan2016 -oct2018), and did not show any significant issue.Conclusion: chromid cps elite performed as expected.

• Brand Name: CHROMID® CPS ELITE
• Type of Device: CHROMID® CPS ELITE
• Manufacturer (Section D): BIOMERIEUX S.A.; 5 rue des aqueducs; craponne, 69290 ; FR 69290
• MDR Report Key: 8034463
• MDR Text Key: 128198232
• Report Number: 3002769706-2018-00229
• Device Sequence Number: 1
• Product Code: JXA
• UDI-Device Identifier: 03573026443900
• UDI-Public: 03573026443900
• 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: 12/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/05/2018
• Device Catalogue Number: 416172
• Device Lot Number: 1006706520
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1