MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® HCG

Model Number	30405-01
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in the united states reported to biomérieux that they observed non repeatable underestimated results when testing patient samples using vidas® hcg 60 tests (ref.30405-01, lot 1009059670, expiry date = 29-oct-2022) compared to another batch.The results were: result on (b)(6) 2022 at 04:02 pm for a new sample of the same patient using vidas hcg 60 tests lot 1009059670: (b)(6).Result on (b)(6) 2022 for a new sample of the same patient using vidas hcg 60 tests lot 1009059670: (b)(6).Result on (b)(6) 2022 for a new sample of the same patient using vidas hcg 60 tests lot 1009059670 : (b)(6).These results were preceded by a valid calibration performed on the (b)(6) 2022.The only information available at the time of this assessment regarding the patient is that she was not trying to get pregnant.The customer reported that they perform qcv weekly and that it was conform.At the time of this assessment, there was no indication that any patient harm occurred as a result fo this issue.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
An internal investigation was performed following notification from a customer in the united states that they obtained non-reproducible results on a patient sample, using vidas hcg ref.30405-01 lot 1009059670.Investigation.1.Device history record.No anomalies occurred during the manufacturing, control and packaging processes on vidas hcg ref.30405-01 lot 100905967.2.Complaint analysis.On the date of the investigation, no similar complaints were recorded for vidas hcg ref.30405-01 lot 1009059670.3.Tests/analysis performed.Products return.No sample was available.Investigation protocol and obtained results.Study of internal samples control charts: this analysis was carried out : - on 5 internal samples (targets between 0,89 and 231 mui/ml); - on 7 batches including the lot mentioned by the customer.All values are within specifications, customer¿s lot is in the trend of the other lots.Test on internal samples.The complaints laboratory tested: - 4 internal samples on retain kit of the lot mentioned by the customer lot 1009059670 results obtained are within the acceptable ranges and similar to those observed before the batch release.No evolution over time of the kit was observed.Repeatability testing.The complaints laboratory tested 2 fresh samples from efs (french blood bank) with the retain kit vidas hcg batch 1009059670.All results are < 2,00 mui/ml.No non-repeatable values obtained.Conclusion.According to all information above, no anomaly was highlighted with the control chart analysis, the analysis of quality data and the tests performed on our internal quality control materials on the retain kit vidas hcg ref.30405-01 lot 1009059670.The complaints laboratory did not reproduce the customer¿s anomaly.An hypothesis of the results obtained by the customer could be a pre-analytical issue (contamination of one of the tubes).Vidas hcg ref 30405-01 lot 1009059670 is within the expected performance.

• Brand Name: VIDAS® HCG
• Common Device Name: 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 69290 ; FR 69290
• Manufacturer Contact: candace martin ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 14121086
• Report Number: 8020790-2022-00048
• Device Sequence Number: 19406014
• Product Code: JHI
• UDI-Device Identifier: 03573026156923
• UDI-Public: 03573026156923
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K141133
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/29/2022
• Device Model Number: 30405-01
• Device Catalogue Number: 30405-01
• Device Lot Number: 1009059670
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2022
• Supplement Date Received by Manufacturer: 05/04/2022
• Initial Report FDA Received Date: 04/15/2022
• Supplement Report FDA Received Date: 05/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown