MAUDE Adverse Event Report: BIOMÉRIEUX SA VIDAS® RUB IGG II

Catalog Number 30221

Device Problem Non Reproducible Results (4029)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

An internal investigation was performed.Investigation results: device history record: there was no capa nor any non-conformity on vidas rub igg ii (ref.30221) linked with customer¿s complaint.Complaint analysis: up to now, no other complaint for a similar issue was recorded on vidas rub igg ii (ref.30221) lot 1008851780.Test/analysis performed: no customer sample was returned and therefore no sample was available for investigation.Control charts analysis: the complaints laboratory analyzed the results of 5 internal samples (targets 17.9 - 11.5 -15.3 ¿ 7.32 and 4.79 ui/ml) using 6 different lots including vidas rub igg ii (ref.30221) lots 1008851780 and 1008940030 mentioned by the customer.The analysis of the control charts showed that all results are within specifications.Customer¿s lot is in the trend of the other lots.Tests performed by complaint laboratory: the complaint laboratory tested 4 internal samples (targets 17.9 - 11.5 -15.3 and 7.32 ui/ml) using retain kits of vidas rub igg ii (ref.30221) customer¿s lot 1008851780 and lot 1008940030.All the results obtained were within specifications, and similar between 2 lots.No significant difference of activity was observed between the 2 lots compared to those observed before the batch release.Support instrument analysis: support instrument analysis has checked the ml2 logs.No instrument issue was detected.Root cause analysis and conclusion: the complaints laboratory did not reproduce the issue observed by the customer when testing internal samples.The complaints laboratory performed tests on four internal samples, using retain kits of vidas rub igg ii (ref.30221) lots 1008851780 and 1008940030 : all sample results were within their expected specifications and similar between the two lots.There was no drift of the customer¿s lot since its release.The root cause has not been identified.Without customer¿s returned samples, the investigation could not be further pursued.According to the investigation above, vidas rub igg ii lots 1008851780 and 1008940030 are still within their expected performances.

Event Description

A customer in (b)(6) notified biomérieux of obtaining non-reproducible positive results when testing patient samples using vidas rub igg ii 60 tests (ref.30221, batch 1008851780, expiry date 08-jul-2022) on their vidas 3 (serial number (b)(4)) compared to another batch.Patient 1, sample id (b)(6): positive result on (b)(6) 2021 using vidas rub igg ii 60 tests batch 1008851780 : 17 iu/ml.The patient¿s history showed numerous negative results for anti-rubella igg since (b)(6) 2021.Equivocal result from retest of the same sample on (b)(6) 2021 using vidas rub igg ii 60 tests batch 1008940030: 10 iu/ml and 12 iu/ml.The anti-rubella virus igm tested negative for this sample patient 1, sample id (b)(6), sample received in november 2020, stored frozen: negative result obtained on (b)(6) 2021 using vidas rub igg ii 60 tests batch 1008940030: 0 iu/ml.Patient 2, sample id (b)(6): positive result on (b)(6) 2021 using vidas rub igg ii 60 tests batch 1008851780 : 23 iu/ml.The patient¿s history showed numerous negative results for anti-rubella igg since september 2021.Positive result from retest of the sample on (b)(6) 2021 using same batch of vidas rub igg ii 60 tests 1008851780: 21 iu/ml.The rubella anti-virus igm tested positive at the limits (0.81) for this sample.Patient 2, different sample (id not provided), sample received in (b)(6) 2020, stored frozen: negative result obtained on (b)(6) 2021 using vidas rub igg ii 60 tests batch 1008851780: 7 iu/ml.No information on igm result from (b)(6) 2021.It is to be noted that a valid calibration was obtained with batch 1008851780 on (b)(6) 2021 and on (b)(6) 2021, and for batch 1008940030 on 28-dec-2021.No further information about patient¿s clinical context were available.It was reported that there was no patient harm.Patient results were not affected, nor was there any delay in reporting them.No wrong result was communicated to the physician.A biomérieux internal investigation has been performed.The investigation is complete.

• Brand Name: VIDAS® RUB IGG II
• Type of Device: VIDAS® RUB IGG II
• Manufacturer (Section D): BIOMÉRIEUX SA; 376 chemin de l'orme; marcy l'etoile 69280 ; FR 69280
• Manufacturer (Section G): BIOMÉRIEUX SA; 376 chemin de l'orme; marcy l'etoile 69280 ; FR 69280
• Manufacturer Contact: dima amro ; 5 rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 13373370
• MDR Text Key: 290416858
• Report Number: 8020790-2022-00021
• Device Sequence Number: 1
• Product Code: LFX
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K141133
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/27/2022

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: 07/08/2022
• Device Catalogue Number: 30221
• Device Lot Number: 1008851780
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/29/2021
• Initial Date FDA Received: 01/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1