MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® CK MB

Catalog Number 30421

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Type  malfunction  

Event Description

A customer in (b)(6) reported a falsely elevated result for an external quality control (eqa) sample in association with the vidas® ck mb assay (lot: 1006158480).The customer reported that for cycle 8, sample 1 the result was too high.The customer stated that eqa was performed once per month and the assay was repeated with similar results.There was no patient involvement as the event pertained to a quality control sample.The customer stated other testing was then performed on different analyzers at different labs.The biomérieux local application specialist requested samples from two different labs to cross check but high results were obtained.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

An internal investigation was performed for a customer in south africa reporting a falsely elevated result for an external quality control (eqa sample "lancet - standton" cycle 8 number 1) sample in association with the vidas® ck mb assay (lot 1006158480).The customer did not submit the sample for evaluation.No sample analysis could be performed.A review of quality records confirmed there was no anomaly during the manufacturing, control and packaging processes, and no capa, or non-conformity recorded for vidas ckmb assay (lot 1006158480).Control chart analysis was performed on five internal samples (target: 44.9-16.1-40.1-74.2-109 ng/ml) on five different batches of vidas ckmb ref 30421 including the customer's (lot 1006158480/181111-0) the analysis showed that vidas ckmb ref 30421 lot 1006158480/181111-0 is in the trend of other batches.Complaint trending analysis showed no other complaint for vidas ckmb assay (lot 1006158480).In conclusion, the vidas ckmb ref 30421 lot 1006158480/181111-0 is within the expected performances.Without the customer's return sample, and as vidas ckmb lot 1006158480/181111-0 has expired, it is not possible to pursue further investigation.

• Brand Name: VIDAS® CK MB
• Type of Device: VIDAS® CK MB
• Manufacturer (Section D): BIOMERIEUX SA; chemin de l orme; marcy l etoile, rhone 69280, ; FR
• MDR Report Key: 8286105
• MDR Text Key: 136858753
• Report Number: 8020790-2019-00007
• Device Sequence Number: 1
• Product Code: JHX
• Combination Product (y/n): N
• PMA/PMN Number: K962549
• 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: 03/12/2019

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: 11/11/2018
• Device Catalogue Number: 30421
• Device Lot Number: 1006158480
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/12/2018
• Initial Date FDA Received: 01/29/2019
• Supplement Dates Manufacturer Received: 02/13/2019
• Supplement Dates FDA Received: 03/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1