MAUDE Adverse Event Report: BIOMÉRIEUX SA CHROMID® CARBA

Catalog Number 43861

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem Misdiagnosis (2159)

Event Type  Injury  

Event Description

A customer from (b)(6) reported a false positive carbapenemase for an escherichia coli isolate with the chromid® carba agar (lot 1006075040).The customer reported the chromid carba result was a pink colony.The result of vitek® 2 ast-n211 card was ertapenem mic <=0.25, meropenem mic <=0.25 s (no imipenem mic test).The customer subcultured the pick colony on both chromid carba and bap media.The customer observed that the sample grew very well with the typical color.The customer performed carba np test and genexpert kpc with the colony on the bap.The results were a weak positive in rapidec carba np and negative in gene xpert.The customer finalized testing as negative.The customer reported that the isolate was detected by the active surveillance culture, so it did not affect patient medication treatment; however, the patient was unnecessarily put into isolation due to the results.According to the lab protocol, the false positive carbapenemase was reported to the physician and then the patient was isolated prior to confirmation testing of pcr, rapidec carba np, and vitek 2.There is no indication or report from the hospital or treating physician to biomérieux that the discrepant result led to any physical adverse event related to the patient's state of health.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

A customer from south korea reported a false positive carbapenemase for an escherichia coli isolate with the chromid® carba agar (lot 1006075040).The customer's patient strain in question was not received for testing.An investigation was performed.A review of quality records confirmed no other complains were received for chromid® carba agar lot 1006075040.A review of the manufacturing records for lot 1006075040 (ref 43861) indicated the lot met all specifications and there was no nonconformance or deviation registered for this lot number.Analysis was performed on the retained sample plates for the impacted lot 1006075040 and on a reference lot number 1006090430, to verify microbiological performance was in accordance with the quality control protocol for ref 43861.The following quality control strains were tested: klebsiella pneumoniae atcc baa-1705, escherichia coli 1011230, serratia marcescens 1008091, klebsiella pneumoniae atcc 700603, escherichia coli atcc 25922, pseudomonas aeruginosa atcc 27853, candida albicans atcc 10231, staphylococcus aureus atcc 25923, serratia marcescens 9203214, serratia marcescens 9304038, and serratia marcescens 9405049.The impacted lot number and the reference lot number were in compliance with described specifications in terms of microbiological activity.Total inhibition of enterobacteria strains (non producers of carbapenamase) was observed.As the customer's patient strain in question was not received for testing, it was not possible to determine the root cause of the issue observed by the customer.The investigation indicated that the impacted lot number is performing within specifications.Of note, the package insert states in the reading and interpretation section; "in any case, carbapenemase production must be confirmed".

• Brand Name: CHROMID® CARBA
• Type of Device: CHROMID® CARBA
• Manufacturer (Section D): BIOMÉRIEUX SA; 5, rue des aqueducs; craponne, fr 69290 ; FR 69290
• MDR Report Key: 7217130
• MDR Text Key: 98167128
• Report Number: 3002769706-2018-00009
• Device Sequence Number: 1
• Product Code: JSI
• Combination Product (y/n): N
• PMA/PMN Number: 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: 04/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/22/2018
• Device Catalogue Number: 43861
• Device Lot Number: 1006075040
• Other Device ID Number: 03573026316952
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other