MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® RUB IGG II - 30221

Catalog Number 30221

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

A customer in (b)(6) notified biomérieux of obtaining a false negative result for a patient sample in association with the vidas® rub igg ii 60 tests (ref.30221, lot 1007517570).The customer stated the patient was a pregnant woman who was confirmed to be positive for rubella igg one month prior.The sample was initially tested using vidas® rub igg lot 1007517570, and obtained a negative result of 0 iu/ml.The customer tested the sample two additional times, both repeat tests yielded positive results of 223 ui/ml and >400 ui/ml.Although repeat testing resulted in a one (1) day delay in reporting results, the customer confirmed the correct result of positive was reported to the treating physician.Biomérieux will initiate an internal investigation.

Manufacturer Narrative

An internal biomérieux investigation was performed for a customer complaint of false negative igg results when testing a patient sample with vidas® rubella igg assay (ref 30221, lot 1007517570).The customer did not submit the patient¿s sample for the investigation.Batch history: there is no capa nor non-conformity recorded on vidas rub igg ii ref.30221 linked to customer's issue batch history records vidas rub igg ii ref.30221 lot 1007517570 showed no anomaly during the manufacturing, control and packaging processes linked to the customer's complaint.Complaint trend: no recurrence of the customer's issue for the impacted lot.Control charts: the complaint laboratory observed four (4) internal samples on seven (7) different batches of vidas rub igg ii ref.30221 including lot 1007517570.R181: 1 iu / ml; ranges [0-3] iu / ml; r237: 5 iu / ml; ranges [2-7] iu / ml; r100: 169 iu / ml; ranges [112-227] iu / ml; r180: 221 iu / ml; ranges [140-303] ui / ml.All results are within specifications; customer's lot is in the trend of the other lots.Tests performed: the complaint laboratory tested four (4) internal samples (r180 and three others) with retain kits of lot 1007517570.There was no anomaly; all values ¿¿for each sample were within specification.The complaint laboratory performed two (2) additional tests without sample and without spr.Without sample or without spr the result is negative with 0rfv.Conclusion: no anomaly was highlighted with the control chart analysis and the analysis of quality data.Hypothesis: as customer's issue was reproduced when performing analysis without sample or spr, the negative result obtained by customer may be linked to an operator error.Without customer's return sample, this hypothesis cannot be confirmed and we cannot pursue further investigation.The investigation concluded vidas rub igg ii ref.30221 lot 1007517570 is within the expected performance.

• Brand Name: VIDAS® RUB IGG II - 30221
• Type of Device: VIDAS® RUB IGG II - 30221
• Manufacturer (Section D): BIOMERIEUX SA; chemin de l orme; marcy l etoile 69280 ; FR 69280
• MDR Report Key: 9595569
• MDR Text Key: 207750259
• Report Number: 8020790-2020-00003
• Device Sequence Number: 1
• Product Code: LFX
• Combination Product (y/n): N
• PMA/PMN Number: K141133
• 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: 03/20/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 07/24/2020
• Device Catalogue Number: 30221
• Device Lot Number: 1007517570
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/17/2019
• Initial Date FDA Received: 01/16/2020
• Supplement Dates Manufacturer Received: 02/19/2020
• Supplement Dates FDA Received: 03/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1