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

Catalog Number 30221

Device Problem False Negative Result (1225)

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

Event Type  malfunction  

Event Description

A customer from (b)(6) reported to biomérieux that they observed negative results when testing a patient sample using vidas rub igg ii 60 tests (ref.30221, batch 1008611770, expiry date 08-jul-2022) on their vidas 3.For the first sample (id (b)(4)): negative result on (b)(6) 2021 using vidas rub igg ii 60 tests batch 1008611770 : 3 iu/ml.This result was obtained after a valid calibration performed on 20-sep-2021.This sample was stored frozen and the customer retested it using a different batch.Positive result from retest on (b)(6) 2021 using vidas rub igg ii 60 tests batch 1008851780 : 259 iu/ml.This result was obtained after a valid calibration performed on (b)(6) 2021.For the second sample (id (b)(4)): positive result obtained on (b)(6) 2021 using vidas rub igg ii 60 tests batch 1008851780: 215 iu/ml.Positive result from retest on (b)(6) 2021 12:12 pm using vidas rub igg ii 60 tests batch 1008851780: 223 iu/ ml both results were obtained after a valid calibration performed on (b)(6) 2021.It is to be noted that for sample id (b)(4), the results for the detection of anti-rubella virus igm were (b)(6).No further information about patient¿s clinical context were available.There was no indication or report of any patient impact.A biomérieux internal investigation has been initiated.

Event Description

A customer from italy reported to biomérieux that they observed negative results when testing a patient sample using vidas rub igg ii 60 tests (ref.(b)(4), batch 1008611770, expiry date 01-mar-2022) on their vidas 3.For the first sample (id (b)(6)): negative result on (b)(6) 2021 using vidas rub igg ii 60 tests batch 1008611770 : 3 iu/ml.This result was obtained after a valid calibration performed on (b)(6) 2021.This sample was stored frozen and the customer retested it using a different batch.Positive result from retest on (b)(6) 2021 using vidas rub igg ii 60 tests batch 1008851780 : 259 iu/ml.This result was obtained after a valid calibration performed on (b)(6) 2021.For the second sample (id (b)(6)): positive result obtained on (b)(6) 2021 using vidas rub igg ii 60 tests batch 1008851780: 215 iu/ml.Positive result from retest on (b)(6) 2021 12:12 pm using vidas rub igg ii 60 tests batch 1008851780: 223 iu/ ml.Both results were obtained after a valid calibration performed on (b)(6) 2021.It is to be noted that for sample id (b)(6), the results for the detection of anti-rubella virus igm were negative: 0.13 iu / ml.No further information about patient¿s clinical context were available.There was no indication or report of any patient impact.A biomérieux internal investigation has been initiated.

Manufacturer Narrative

A customer in italy notified biomérieux of observing negative results when testing patient samples using vidas rub igg ii 60 tests (ref.(b)(4), batch 1008611770, expiry date 01-mar-2022) on their vidas 3.On (b)(6) 2021, sample (b)(6) tested using vidas rub igg ii 60 tests lot 1008611770, result 3 ui/ml (negative).On (b)(6) 2021, sample (b)(6) tested using vidas rub igg ii 60 tests lot 1008851780, result 215 ui/ml (positive).Both samples of this same patient were retested in parallel on 30-oct-2021 using vidas rub igg ii 60 tests lot 1008851780: - sample 01833143 result 259 ui/ml (positive).- sample 01961550 result 223 ui/ml (positive).An internal investigation was performed.Investigation results: no sample was available for investigation.1- batch history record: no anomaly during the manufacturing, control and packaging processes for vidas rub igg ii 60 tests (ref.(b)(4)).2- complaint analysis: up to now, no other complaint was recorded on vidas rub igg ii 60 tests lot 1008611770.3- control charts analysis: the analysis of four (4) internal samples with different targets (221 ¿ 4.79 ¿ 5.28 and 146 ui/ml using six (6) vidas rub igg ii lots including customer's lots 1008611770 and 1008851780 show that the concerned lots gave results within specifications and are in the trend compared to the other lots.4- support instrument analysis: support instrument analysis has checked the ml2 logs to control the pump performance.The pressure, the apu and the scanner were conform.There is no instrument issue.5-tests performed by complaint laboratory: the complaint laboratory tested 2 internal samples using 2 lots of vidas rub igg ii (ref.(b)(4)): 1008611770 and 1008851780 mentioned by customer.The 2 internal samples gave expected values and similar between the 2 lots.6- conclusion: ml2 logs analysis, by support instrument, shows that there is no instrument issue.The complaint laboratory has compared 2 internal samples on 2 lots 1008611770 and 1008851780 mentioned by customer, the results are similar and gave expected values.The root cause has not been identified.Without customer¿s return sample, investigation cannot be further pursued.According to the investigation above vidas rub igg ii (ref.(b)(4)) lot 1008611770 is still within expected performance.

• Brand Name: VIDAS® RUB IGG II
• Type of Device: VIDAS® RUB IGG II
• Manufacturer (Section D): BIOMERIEUX SA; 376 chemin de l'orme; marcy l'etoile 69280 ; FR 69280
• Manufacturer (Section G): BIOMERIEUX 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: 12925127
• MDR Text Key: 289332090
• Report Number: 8020790-2021-00337
• 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,Followup
• Report Date: 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2022
• Device Catalogue Number: 30221
• Device Lot Number: 1008611770
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1