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

Catalog Number 30221

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

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

Event Date 04/17/2019

Event Type  malfunction  

Event Description

A customer in (b)(6) reported a false positive result in association with the vidas® rub igg ii assay.The customer reported that on (b)(6) 2019, the isolate was first tested on dxi (beckman) and was negative (9.28 ui/).Using the vidas 3 instrument, the isolate was first run in position d1 and the result was positive (55 ui/ml).The repeat test was in position a1 and the result was negative (8 ui/ml).A retest on dxi gave a negative result (9.84 ui/ml).The customer reported that no wrong result was reported to the physician.There is no indication or report from the hospital or treating physician to biomérieux that the discrepant result led to any adverse event related to the patient's state of health.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

An internal investigation was performed for a false positive result in association with the vidas® rub igg ii assay.Batch history records and trend analysis: there is no other complaint on this batch for the same issue.There is no capa, or non-conformity linked with the customer 's complaint.The analysis of the batch history records showed no anomaly during the manufacturing, control and packaging processes.Study of internal samples control charts: this analysis was carried out on four internal sample with different concentrations, on six batches including the batch mentioned by the customer.All the results were within specifications.Vidas rub igg ii batch 1006971560 / 191126-0 is in the trend compared to the other batches.Tests performed: the customer submitted two samples for evaluation.The laboratory performed a calibration and tested the two samples with retained kit vidas rub igg ii 1006971560 / 191126-0 on a vidas 3 instrument in automatic position.The two results were negative = 8 ui/ml.The laboratory performed tests with retained kit vidas rub igg ii 1006984570 / 191126-1 (same reagents and same mle data) on vidas 3 in automatic.The two results were negative = 9 ui/ml.The high result (55ui/ml) reported by the customer was not reproduced.Analysis of the logs: no problem or difference between aspirations performed by the pipettor were observed, considering all the sample positions, for all the rub igg ii analysis done between march 26 and april 17.No problem or difference between aspirations and dispensations performed by the section pumps were observed, for all the rub igg ii analysis done between march 26 and april 24.Conclusion: the investigation did not reproduced the customer's anomaly.The most probably hypothesis is a preanalytical issue during the first test as this result did not match with other negative results.According to the investigation results, vidas rub igg ii 1006971560 / 191126-0 performed as expected.

• Brand Name: VIDAS® RUB IGG II
• Type of Device: VIDAS® RUB IGG II
• Manufacturer (Section D): BIOMERIEUX SA; chemin de l orme; marcy l etoile, rhone 69280, ; FR
• MDR Report Key: 8606427
• MDR Text Key: 195711014
• Report Number: 8020790-2019-00028
• 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: 06/26/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 11/26/2019
• Device Catalogue Number: 30221
• Device Lot Number: 1006984570
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/17/2019
• Initial Date FDA Received: 05/13/2019
• Supplement Dates Manufacturer Received: 06/06/2019
• Supplement Dates FDA Received: 06/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1