MAUDE Adverse Event Report: BIOMÉRIEUX SA CHROMID S. AUREUS

Catalog Number 43371

Device Problem False Negative Result (1225)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/16/2015

Event Type  malfunction  

Event Description

A customer in (b)(6) reported a false negative result with chromid (b)(6) agar (ref.43371, lot 1003864180, expiration 08-jul-2015).The customer stated that colonies of (b)(6) organism did not develop any color.As stated in the ifu (instruction for the use), the colonies of (b)(6) organism should be very pale green to dark green in color.The customer then sub-cultured the organism colonies from the incriminated chromid (b)(6) plates onto a different lot number (1003938520) of chromid (b)(6) agar plates.After incubation, organism colonies produced are green in color.No information has been provided regarding patient prescribed therapy, or if the discrepant negative chromid (b)(6) agar result impacted treatment decisions.There is no indication or report from the hospital or treating physician to biomérieux that the discrepant result led to any adverse event related to the patient's state of health.Culture submittals have been requested for internal investigation.

Manufacturer Narrative

Device not returned to manufacturer.

Manufacturer Narrative

An investigation was conducted to verify the conformity of the implicated batch 1003864180, chromid s.Aureus agar, ref (b)(4).For this batch number, the customer observed a growth of a staphylococcus aureus with no typical green colony color.Submittal of the patient isolate(s) was requested by biomérieux; however, the customer did not comply.Review of complaint records indicates no other complaint registered against this reference number and batch number.Review of the batch record confirmed that no anomaly was detected during manufacturing or quality control testing to explain the issue reported by the customer.For the release of the batch after its manufacturing, the results of the microbiological quality control are in accordance with specifications.The investigation included retained samples of the customer batch of chromid s.Aureus (1003864180), in parallel with another batch of chromid s.Aureus agar (1003938520, expiry date 06aug15), using the same strains as used during product release tests.After an incubation of 20-24h, the strain of s.Aureus atcc 6538 presents green colonies, with the same results for both batches.The strain of s.Aureus atcc 25923 presents green colonies in the mass; the isolated colonies are pale green to colorless for the "reference" batch and colorless for the customer batch.After an incubation of 48h all the results are correct for the reference batch and the customer batch : good growth of staphylococcus aureus atcc 25923 with characteristic green colonies.Good growth of staphylococcus aureus atcc 6538 with characteristic green colonies.Since the customer did not provide a submittal of the patient strain, no further testing is possible to identify if the strain meets any of the limitations indicated in the instructions for use (package insert 43371).The investigation concluded that the performance of chromid s.Aureus agar ref (b)(4), batch 1003864180 is within specification.

• Brand Name: CHROMID S. AUREUS
• Type of Device: CHROMID S. AUREUS
• Manufacturer (Section D): BIOMÉRIEUX SA; 5, rue des aqueducs; craponne, fr 6929 0; FR 69290
• Manufacturer (Section G): BIOMERIEUX, INC; 595 anglum road; st. louis MO 63042
• Manufacturer Contact: ryan lemelle ; 595 anglum road; hazelwood, MO 63042 ; 3147318582
• MDR Report Key: 4888163
• MDR Text Key: 6066279
• Report Number: 3002769706-2015-00053
• Device Sequence Number: 1
• Product Code: JWX
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/16/2015

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
• Device Operator: Health Professional
• Device Expiration Date: 07/08/2015
• Device Catalogue Number: 43371
• Device Lot Number: 1003864180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/16/2015
• Initial Date FDA Received: 07/02/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1