MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® HCG

Catalog Number 30405

Device Problem Low Test Results (2458)

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

Event Date 02/03/2023

Event Type  malfunction  

Event Description

On (b)(6) 2023, a customer in austria notified biomérieux of a possible false negative result when testing with vidas® hcg 60 tests (ref.30405, lot #1009567820, expiry date: (16-aug-2023) with a patient sample.On the (b)(6) 2023, the sample was tested a first time and the result was <2.00 mui/ml.The same day, the same sample was tested again and the result was 1184.34 mui/ml.The sample tested with rapid-test with urine gave a positive result.Ultrasound test was also realized and the result was positive as well.The wrong result was given to the physician.The customer reported that there was no patient harm or incorrect treatment due to the referenced issue nor delayed result.A biomérieux internal investigation has been initiated.Note: reference 30405 is not registered in the united states.The u.S.Similar device is product reference 30405-01.

Manufacturer Narrative

On 16-mar-2023, a customer in austria notified biomérieux of a possible false negative result when testing with vidas® hcg 60 tests (ref.(b)(4), lot #1009567820, expiry date: 16-aug-2023) with a patient sample.1.Device history record the review did not highlight any issue during manufacturing processes for vidas hcg ref (b)(4) lot 1009567820.2.Complaint analysis the complaint analysis did not reveal this issue as a systemic quality issue for the impacted lot.3.Tests/analysis performed **control charts analysis** this analysis was carried out on vidas® hcg ref (b)(4).- for 4 internal samples (respective targets 1287 miu/ml, 657 miu/ml, 1033 miu/ml and 640 miu/ml).- for 10 lots including the lot mentioned by the customer => all values were within specifications, customer¿s lot was in the trend of the other lots **tests performed by complaint laboratory on internal samples** the complaint laboratory tested 3 different internal samples on the retain kits vidas® hcg ref (b)(4) lot 1009567820 with target at 1033.0 mui/ml, 657.00 mui/ml, 1287.00 mui/ml.Internal samples test values were similar to those observed before the lot release.Biomérieux did not observe any evolution over time of the customer¿s lot since its release.For complementary tests the complaint laboratory carried out tests without sprs or without sample in the well with retain kits vidas® hcg ref (b)(4) lots 1009567820.Results were <2 miu/ml with rfv between -1 and 3.These results are similar to the value obtained by customer for the first sample.4.Root cause analysis and conclusion - the potential root cause has been identified (pre-analytical issues): - root cause 1 : no solid phase receptacles (sprs).- root cause 2 : no sample in the well before launch the run.According to all information above, no anomaly was highlighted with the control chart analysis, the analysis of quality data and the tests performed on retain kits vidas® hcg ref (b)(4) lot 1009567820.There is no reconsideration of the performance of vidas® hcg ref (b)(4) lot 1009567820 to its expectations.

• Brand Name: VIDAS® HCG
• Type of Device: VIDAS® HCG
• 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: romain marti ; 5 rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 16684252
• MDR Text Key: 313060677
• Report Number: 8020790-2023-00023
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 05/10/2023

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: 08/16/2023
• Device Catalogue Number: 30405
• Device Lot Number: 1009567820
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/16/2023
• Initial Date FDA Received: 04/05/2023
• Supplement Dates Manufacturer Received: 05/05/2023
• Supplement Dates FDA Received: 05/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1