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 no result (no growth) for an external quality control (eqa) sample (neqas distribution 4341 sample 4569) on chromid® cps elite agar (lot 1006606560).The expected result of the eqa sample was staphylococcus saprophyticus.When the customer obtained the results of the neqas survey, they asked for a repeat sample.The customer then tested a second lot (100666680) of chromid cps elite, and also cultured the eqa sample onto blood agar and cled (cystine lactose electrolyte deficient) medium.The result was no growth on chromid cps elite, while staphylococcus saprophyticus grew on both blood agar and cled.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 lot 1006606560 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 if the shelf life of the product the sensitivity could change.- two chromid cpse customer lots (1006606560 and 100666680).- two chromid cpse lots with the same expiry of both customer lots.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 strains.The lots 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: 8062048
• MDR Text Key: 129156750
• Report Number: 3002769706-2018-00236
• 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: 11/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/23/2018
• Device Catalogue Number: 416172
• Device Lot Number: 1006606560
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1