MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® C. DIFFICILE GDH; VIDAS® GDH

Catalog Number 30125

Device Problem Failure to Calibrate (2440)

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

Event Type  malfunction  

Event Description

A customer from (b)(6) notified biomérieux of calibration problems with vidas® gdh (ref 30125).The customer was performing calibration testing with a new lot (1006161620 / 190127-0) on (b)(6) 2018 and obtained invalid calibration results.The customer notified biomérieux on (b)(4) 2018 of the issue, and by the end of the day, the calibration was valid.There were patient samples waiting more than 24 hours to be tested.There is no indication from the laboratory that there was any adverse event related to any patient's state of health due to this issue.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

An internal biomérieux investigation was performed after a customer reported calibration problems with vidas® gdh (ref 30125).The customer notified biomérieux of a positive control c1 out of range on vidas gdh lot 1006161620/190127-0.The customer obtained: 06apr2018: tv 0.45/0.43 (ranges : 0.17-0.33 with the first c1 vial.09apr2018: tv 0.27 with a second c1 vial from same kit.Result was in conformance.Batch record review: there is no capa nor nonconformity recorded on vidas gdh 1006161620/190127-0 linked to the customer's issue.The analysis of the batch history records of vidas gdh 1006161620/190127-0 showed no anomaly during the manufacturing, control, and packaging processes.Biomerieux testing results: the calibration tested on the retained kit was in conformance and similar with the identity kit (in normal condition of reconstitution, as indicated in the package insert).For additional testing, 1ml of distilled water was put in the c1 vial instead 2 ml, before treated by the r1 vial.The result obtained was not in conformance with a tv=0.46.Therefore, the customer's anomaly was reproduced during the internal investigation if the c1 vial was reconstituted with 1 ml of distilled water instead 2 ml.As a result, the test value (tv) was increased.Biomérieux identified the root cause as a probable error in reconstitution of the c1 vial by the technician, c1 vial reconstituted with 1 ml instead 2 ml of distilled water.In conclusion, vidas gdh lot 1006161620 is in the expected specification.

• Brand Name: VIDAS® C. DIFFICILE GDH
• Type of Device: VIDAS® GDH
• Manufacturer (Section D): BIOMERIEUX SA; 376, chemin de l'orme; marcy l'etoile, 69280 ; FR 69280
• MDR Report Key: 7477463
• MDR Text Key: 107754924
• Report Number: 3002769706-2018-00062
• Device Sequence Number: 1
• Product Code: MCB
• Combination Product (y/n): N
• PMA/PMN Number: K132010
• 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: 07/11/2018

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: 01/27/2014
• Device Catalogue Number: 30125
• Device Lot Number: 1006161620
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/08/2018
• Initial Date FDA Received: 05/01/2018
• Supplement Dates Manufacturer Received: 06/12/2018
• Supplement Dates FDA Received: 07/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1