MAUDE Adverse Event Report: BIOMÉRIEUX ESPAÑA GRANADA AGAR; GRANADA¿ AGAR

Model Number 43712

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Type  malfunction  

Manufacturer Narrative

An internal biomérieux investigation was performed.The clinical strain was not able to survive; the investigation was performed with the strains from the biomerieux quality control lab collection due to concern as to how the clinical strains were collected and transported, directly on gran medium.After primary isolation either on schaedler broth agar supplemented with vitek® knowledge base 3 or cos medium described: no anomalies were observed during a review of the manufacturing records (device history record).Microbiological control prior its releasing the batch were as expected and within current specifications; therefore, based on the inspection of the batch record, the root cause at the manufacturing level cannot be determined.The clinical control strain were inoculated under regular qc control using s.Agalactiae atcc 12386, which are identified as gbs strains as the strain from the customer is not available anymore.Likewise, the retention sample was tested in parallel with other batches manufactured at different times from the manufacturing date, in order to determine if the defect of the performance seen by customer is reproduced in another batch.It is important to note that the complaint batch expired as of 12may2017.Furthermore, columbia blood agar, used as control to ensure the recovery and beta-hemolytic reaction of all target strains is intended.Reading was performed after incubation under aerobic conditions at 33- 37 º c for 18-24 hours.After incubation, in all cases (even with the complaint batch that had already expired), results were within specifications and the intensity of coloration was as expected for all strains tested, typical orange pigment developed in all cases.In conclusion, s.Agalactiae atcc 12386, which is the atcc used in routine qc, remains good with positive and it is not related to the product itself.Further investigation is not possible due to the need for the customer's strain in the product information, it is already defined in the methods limitation that certain strains may not produce typical color.Some strains of s.Agalactiae may not produce typical colonies, particularly non-hemolytic strains (2.3 %).

Event Description

A customer in (b)(6) notified biomérieux of a discrepant result associated with granada¿ agar (reference 43712) involving an external quality control sample (cqe lab quality).The customer reported obtaining a white colony on the plate.The customer reported two (2) patient strains with this problem.The specimen from the first patient was inoculated directly on the agar plate.

• Brand Name: GRANADA AGAR
• Type of Device: GRANADA¿ AGAR
• Manufacturer (Section D): BIOMÉRIEUX ESPAÑA; isaac newton, 6; tres cantos; madrid, 28760 ; SP 28760
• Manufacturer (Section G): BIOMÉRIEUX ESPAÑA; isaac newton, 6; tres cantos; madrid, 28760 ; SP 28760
• Manufacturer Contact: ellen weltmer ; 595 anglum road; saint louis, MO 63042
• MDR Report Key: 6671114
• MDR Text Key: 78783671
• Report Number: 3002769706-2017-00150
• Device Sequence Number: 1
• Product Code: JSO
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: CI EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/27/2017

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: 05/02/2017
• Device Model Number: 43712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/30/2017
• Initial Date FDA Received: 06/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2017
• 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