MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS D DIMER EXCLUSION II; VIDAS® D DIMER EXCLUSION¿ II

Catalog Number 30455-01

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

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

A customer in the united states reported out of range low results for proficiency samples from the american proficiency institute (api) in association with the vidas® d dimer exclusion¿ ii assay.The customer reported the cardiac marker test of samples cm-06 and cm-08 for the d-dimer received a grade of unacceptable (60%).The expected result for sample cm-06 was 0.375-0.543ug feu/ml and the customer reported 0.374ug feu/ml.The expected result for sample cm-08 was 1.388-1.987ug feu/ml and the customer reported 1.364ug feu/ml.The samples were repeated with a different strip lot and were in range, in which sample cm-06 was 0.471ug feu/ml.And cm-08 was 1.678ug feu/ml.There was no patient involvement as the event pertained to a proficiency sample.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

An investigation was completed in response to a customer complaint of out of range low results for proficiency samples from the american proficiency institute (api) in association with the vidas® d dimer exclusion¿ ii assay (lot 1006974360 / 191120-0).The customer reported the cardiac marker test of samples cm-06 and cm-08 for the d-dimer received a grade of unacceptable (60%).The customer did not have enough sample material left to send for investigational testing.----complaint trending---- since 2018, there have been 13 complaints recorded for the vidas® d dimer exclusion¿ ii assay for external quality control issue.There have been five (5) complaints recorded for the customer's lot (1006974360 / 191120-0), but no other complaints were related to the customer's issue.----batch history record---- review of production records for lot 1006974360 / 191120-0 indicated that there were no anomalies during the manufacturing, control, and packaging processes.----control charts---- four (4) internal sera were tested on eight (8) lots, including the customer's lot (1006974360 / 191120-0).Dex2-46 target 426 ng/ml (feu) ranges [358-494] ng/ml (feu) : near customer cm-06 value dex2-50 target 1415 ng/ml (feu) ranges [1226-1604] ng/ml (feu) : near customer cm-08 value.Dex2-52 target 3832 ng/ml (feu) ranges [3306-4358] ng/ml (feu).Dex2-44 target 5121 ng/ml (feu) ranges [4390-5853] ng/ml (feu).Results were within specifications, customer's lot in the trend of the other vidas ddex2 batches.----testing performed in complaints laboratory---- three (3) internal samples and two (2) labquality qc samples, with expected values near the customer's cm-06 and cm-08) were tested with a retained vidas® d dimer exclusion¿ ii assay kit from the customer's lot (1006974360 / 191120-0).The results obtained were within the acceptable ranges and were similar to values obtained at batch release.----conclusion---- the customer's out of range low results were not reproduced internally.The vidas® d dimer exclusion¿ ii assay kit (lot 1006974360 / 191120-0) is performing as expected.

• Brand Name: VIDAS D DIMER EXCLUSION II
• Type of Device: VIDAS® D DIMER EXCLUSION¿ II
• Manufacturer (Section D): BIOMERIEUX SA; chemin de l orme; marcy l etoile, rhone 69280, ; FR
• MDR Report Key: 8933393
• MDR Text Key: 209790977
• Report Number: 8020790-2019-00051
• Device Sequence Number: 1
• Product Code: DAP
• UDI-Device Identifier: 03573026387006
• UDI-Public: 03573026387006
• Combination Product (y/n): N
• PMA/PMN Number: K112818
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 11/19/2019

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: 11/20/2019
• Device Catalogue Number: 30455-01
• Device Lot Number: 1006974360
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/30/2019
• Initial Date FDA Received: 08/26/2019
• Supplement Dates Manufacturer Received: 10/22/2019
• Supplement Dates FDA Received: 11/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1