MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® HCG

Model Number	30405-01
Medical Device Problem Code	Non Reproducible Results (4029)
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 notified biomérieux that they observed non repeatable underestimated results when testing a patient¿s samples using vidas hcg 60 tests (lot 1009059670, expiry date 29-oct-2022).On (b)(6) 2022.The patient¿s first sample was drawn on (b)(6) 2022 and tested with the result : 133.81 mui/ml.This sample was retested on (b)(6) 2022 and the result was 33.33 mui/ml.The same sample was stored in the fridge and tested on (b)(6) 2022: 4050 mui/ml and 4000 mui/ml on section b.A new sample was drawn and tested on (b)(6) 2022.The results for this same sample after dilution b 1/20 were the following: - result 10:43 am in a2 position: 5974.59 mui/ml - result at 11:15 am in b2 position: 6494.57 mui/ml the customer stated that they are concerned there is too much difference between the results obtained with the first sample and the second and not sure if this patient is considered pregnant.These results were preceded by a valid calibration performed on (b)(6) 2022.The last qcv results on (b)(6) 2022 on sections a and b, show that there is no problem with the mini vidas instrument.At the time of this assessment, there was no indication that any patient harm occurred as a result of this issue.A biomérieux internal investigation will be initiated.

• 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 69280 ; FR 69280
• Manufacturer Contact: dima amro ; 5 rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 15296956
• Report Number: 8020790-2022-00090
• Device Sequence Number: 16792943
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/25/2022

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 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: 07/26/2022
• Initial Report FDA Received Date: 08/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown