MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® HCG 60 TESTS

Model Number	30405-01
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer from united states notified biomérieux of obtaining overestimated result when testing external quality control on vidas hcg 60 tests (ref.30405-01, batch number: 1009059670, expiry date: 29-oct 2022).The customer reported that the external controls level 3 result was too high when analyzed with vidas hcg 60 tests (ref.30405-01, batch number: 1009059670).The customer did not provide the result obtained and expected with the external controls level 3.The customer also mentioned that the controls provided in the vidas kit were conform.The customer also compared these external results with another instrument that's not a minividas.Following this issue, the customer requested an fse (field service engineer) to be dispatched on site.As it was an external quality control, no patient sample was involved.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 overestimated result when testing external quality control on vidas hcg 60 tests (ref.30405-01, batch number: 1009059670, expiry date: 29-oct-2022).The quality control sample (level 3, lot: 40413) gave an initial result of 488.08 iu/ml for an expected range of [222-388] and then the quality control sample gave a result of 283.97 iu/ml when tested again.Unfortunately, it was not possible to get more information about the conditions of initial run and rerun ( including the signals measured, positions on the instrument, calibration data, if same vial of qc sample used).Investigation: no material received from the customer.Complaint analysis: as of the date of this investigation, we have recorded only this customer¿s complaint for performance issue on vidas hcg lot: 1009059670.Control chart analysis: analysis was carried out on four (4) internal samples with respective targets between 2.00 and 231 miu/ml, using seven (7) batches of vidas hcg including the customer¿s lot: (1009059670).All results are within specifications and the lot mentioned by the customer is consistent compared to the other lots.Internal sample testing: the complaints laboratory tested 4 internal samples ( targets < 2.68 / 1.08 / 5.11 / 36.3 and 156 miu/ml) on the retain kit of vidas hcg lot: 1009059670 (lot mentioned by the customer).The results complied with the specifications without any significant difference compared to those observed before the batch release.Biomérieux did not observe any evolution over time of these samples activity.Quality control testing: the complaints laboratory tested a specimen of the quality control sample lyphocheck immunoassay control plus level 3, lot: 40413 (already in stock in our laboratory) on the retain kit of vidas hcg lot: 1009059670.The quality control sample tested in duplicate gave a result of 302.54 and 283.59 miu/ml so within the acceptable range established by biorad {222-388} and not so far from the target of 305 miu/ml.Conclusion: the complaints laboratory did not reproduce the issue reported by the customer (result too high) when testing internal samples and the sample ¿lyphocheck immunoassay plus control¿ level 3, lot: 40413 on vidas hcg lot: 1009059670.Without the customer¿s material available and relevant information concerning the operating conditions, it was not possible to pursue further the investigation and we did not manage to identify any obvious root cause.According to the data mentioned above, there is no reconsideration of vidas hcg ref.30405-01, lot: 1009059670.

• Brand Name: VIDAS® HCG 60 TESTS
• Common Device Name: VIDAS® HCG 60 TESTS
• 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: candace martin ; 595 anglum road; hazelwood, MO
• MDR Report Key: 14644522
• Report Number: 8020790-2022-00067
• Device Sequence Number: 5109231
• 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,Followup
• Report Date (Section B): 07/24/2022

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: 05/12/2022
• Supplement Date Received by Manufacturer: 07/12/2022
• Initial Report FDA Received Date: 06/09/2022
• Supplement Report FDA Received Date: 07/24/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown