MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® CMV IGG

Catalog Number	30204-01
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in the united states reported a (b)(6) result for a (b)(6) survey sample (survey (b)(6), sample (b)(6)) in association with the vidas® cmv (cytomegalovirus) igg assay the customer stated they reported that (b)(6) igg antibodies were (b)(6).Their (b)(6) result was (b)(6).The expected result was (b(6) igg antibodies (b)(6).Biomérieux requested the (b)(6) survey report and instructions, and the customer's test reports.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
A customer in the united states reported a false positive result for a cap survey sample (survey vr3-b2018, sample vr3-09) in association with the vidas® cmv (cytomegalovirus) igg assay (reference 30204-01 lot 1006388970).The customer reported that cmv igg antibodies were present.Their positive result was 7ua/ml.The expected result was cmv igg antibodies not present (negative).Biomérieux initiated an investigation which included a review of applicable complaints and quality control records, review of cap survey report as well as internal testing.The documentation review showed no indication of a trend nor any anomalies associated with the manufacturing or packaging processes for lot 1006388970.Quality control sample vr3-9 was tested on four vidas cmv igg batches.Batch 1006388970 was not tested as this lot had expired prior to investigational testing.All the results were equivocal with a concentration of 5 ua/ml.A review of the cap survey report showed that this survey sample is cmv igm positive.Additionally, clsi guideline ep14-a3 states that processed samples used as qc material (e.G eqa) can have matrix effect.To conclude, vidas cmv igg product ref 30204 is performing as intended.

• Brand Name: VIDAS® CMV IGG
• Common Device Name: VIDAS® CMV IGG
• Manufacturer (Section D): BIOMERIEUX SA; chemin de l orme; marcy l etoile, rhone 69280, ; FR
• MDR Report Key: 8322648
• Report Number: 8020790-2019-00010
• Device Sequence Number: 1691388
• Product Code: LFZ
• UDI-Device Identifier: 03573026156831
• UDI-Public: 03573026156831
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K920661
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/06/2019
• Device Catalogue Number: 30204-01
• Device Lot Number: 1006388970
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2019
• Supplement Date Received by Manufacturer: 03/19/2019
• Initial Report FDA Received Date: 02/08/2019
• Supplement Report FDA Received Date: 04/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1