MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® CK MB

Catalog Number 30421

Device Problem False Positive Result (1227)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/09/2018

Event Type  malfunction  

Event Description

A customer from (b)(6) notified biomérieux of obtaining elevated ck-mb results for a (b)(6) boy in association with the vidas® ck mb assay (ref (b)(4)).Although product reference (b)(4) is not sold/ distributed in the united states, a similar product is (reference (b)(4)).The patient had complained of a stabbing pain his chest after exercise.He had moved benches at school and played football.He was admitted to the children's ward for observation, and labs were drawn showing the following results: (b)(6) 2018: troponin - 10.1 ng / ml, ck-mb - 116.15 ng / ml, ecg - normal.(b)(6) 2018: troponin - 3.6 ng / ml, ck-mb - 133.97 ng / ml.(b)(6) 2018: ck-mb - 202.99 ng / ml, repeated in serum diluted 11 times = 17.1 ng / ml x 11 = 188.1 ng / ml.The chest pain was transient, and the patient was reported by the customer as feeling well.As the vidas ck-mb test was performed after a sport exercise at school, the elevation of ck-mb could have been due to muscular hyperactivity.However, the result continued to increase.The customer reported testing one of the patient samples with the vidas ckmb assay and obtaining a > 300 result.This same sample was testing with cobas® (roche diagnostics), and it returned a ck-mb result in the normal range.The customer reported that the patient was discharged home without treatment.There is no indication or report from the laboratory that the discrepant result led to any adverse event related to any patient's state of health.Note: the two techniques, vidas and cobas, use different technologies and different antibodies for the detection of ck-mb.An internal biomérieux investigation will be initiated.

Manufacturer Narrative

An internal investigation was performed for elevated ck-mb results for a 14-year-old boy in association with the vidas® ck mb assay (ref 30421).Complaint trending analysis confirmed there is no other complaint on this lot vidas ckmb 1006271330 /190117-0 for the same issue.The batch history records for the lot vidas ckmb 1006271330 /190117-0 show no anomaly during the manufacturing and control process, and no non-conformity.A study of internal sample control charts for five internal samples with different concentrations on six batches including the batch mentioned by the customer, confirmed results were within specifications.Vidas ckmb 1006271330 /190117-0 is in the trend compared to the other batches.Testing included six internal samples with the lot vidas ckmb 1006271330 /190117-0.The results were within the expected values and there was no evolution since batch release.Ckmb64 :19.79 ng/ml ckmb41 :72.24 ng/ml ckmb54 :27.84 ng/ml ckmb37 :184.33 ng/ml ck13 : 1.76ng/ml ck21 : 1.66ng/ml regarding these six internal samples, we did not reproduced the customer's anomaly.The elevated result with vidas ckmb seems to be linked to the specific sample.Without the customer sample we cannot pursue the investigation.Note: the two techniques mentioned by the customer, vidas and cobas, use different technologies and different antibodies.

• Brand Name: VIDAS® CK MB
• Type of Device: VIDAS® CK MB
• Manufacturer (Section D): BIOMERIEUX SA; 376 chemin de l orme; marcy l etoile, rhone 69280 ; FR 69280
• MDR Report Key: 8056317
• MDR Text Key: 129157436
• Report Number: 3002769706-2018-00235
• 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: 12/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/17/2019
• Device Catalogue Number: 30421
• Device Lot Number: 1006271330
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 14 YR