MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® MEASLES IGG

Model Number	30219
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 (b)(6) notified biomérieux of false negative results for two neqas survey strains in association with vidas® measles igg (ref.30219 lot 1007322860).Both survey strains were tested in duplicate, results were: neqas strain 5248: 0.4, 0.42 negative; neqas strain 5249: 0.49, 0.40 negative.It was confirmed the expected result for both neqas survey strains was positive.As there are no patients associated with these quality control strains, there is no adverse event related to any patient's state of health.Biomérieux will initiate an internal investigation.
Additional Manufacturer Narrative
This report was initially submitted following notification from a customer in ireland regarding false negative results for two neqas survey strains in association with vidas® measles igg (ref.30219 lot 1007322860).A biomérieux internal investigation was completed.There is no other complaint for an external quality control problem on the vidas msg batch 1007322860 / 200325-0.No recurrence of a particular anomaly.According to the analysis of the quality data, there was no anomaly during the manufacturing, control and packaging stages.No capa or non-compliance is related to the reason for the complaint.Control cards were used with five positive sera from internal serotheque that were analyzed on eight lots of vidas msg including the client lot.All the samples analyzed complied with the specification, but vidas measles igg lot 1007322860 / 200325-0 was in the low trend compared to the other lots.The complaint laboratory tested the vidas msg pv kit 1007322860 / 200325-0, a biobank serum 156234-ser, as well as five serums from internal serotheque.Internal serums were within expected standards although some were located on the lower limit.Serum 156234-ser from biobank obtained a negative result on lot 200325-0 but was positive on diasorin.Vms (validation, metrology, support) investigated sample 5248 and sample 5249.Sample 5248 was negative for all three lots.Sample 5249 was negative for two lots and positive for one.It was concluded that the inter-batch variability was consistent with the precision profile of the parameter.No significant difference was observed between the lots of vidas msg.In conclusion, the vidas msg 1007322860 / 200325-0 batch still complied with its specifications.

• Brand Name: VIDAS® MEASLES IGG
• Common Device Name: VIDAS® MEASLES IGG
• Manufacturer (Section D): BIOMERIEUX SA; 376 chemin de l orme; marcy l etoile 69280 ; FR 69280
• MDR Report Key: 9765946
• Report Number: 8020790-2020-00020
• Device Sequence Number: 13631825
• Product Code: LJB
• UDI-Device Identifier: 03573026064532
• UDI-Public: 03573026064532
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: C1 EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2020

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: 03/25/2020
• Device Model Number: 30219
• Device Catalogue Number: 30219
• Device Lot Number: 1007322860
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2020
• Supplement Date Received by Manufacturer: 05/15/2020
• Initial Report FDA Received Date: 02/27/2020
• Supplement Report FDA Received Date: 06/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1