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 2018 (b)(6) sample (b)(6) in association with the vidas® cmv igg assay.The customer twice obtained a (b)(6) result, when the expected result was (b)(6).There was no patient involvement.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: 8350673
• Report Number: 8020790-2019-00014
• Device Sequence Number: 2138227
• Product Code: LFZ
• UDI-Device Identifier: 03573026156831
• UDI-Public: 03573026156831
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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 an Adverse Event Report?: No
• 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: 01/21/2019
• Supplement Date Received by Manufacturer: 03/19/2019
• Initial Report FDA Received Date: 02/19/2019
• 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