MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS HCG; VIDAS® HCG

Catalog Number 30405

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 07/23/2021

Event Type  malfunction  

Event Description

On (b)(6) 2021, a customer from (b)(6) reported to biomérieux that they observed invalid results leading to delayed results with a patient sample tested using vidas hcg 60 tests (ref.30405, lot 1008714630, expiry date = 26-apr-2022).The results were outside the range of measurement of the kit so the customer proceeded to dilutions as per package insert for vidas hcg 60 tests (ref.30405): the measurement range of the kit is: 2-1500 miu/ml and samples with hcg concentrations greater than 1,500 miu/ml may be reassayed after diluting by 1/20 to 1/200 with the hcg diluent (r1).The results obtained on 23-jul-2021 were the following: result at 08:36 am after dilution by 1/5 : > 7500 mui/ml.Result at 09:09 am after dilution by 1/10 : > 15000 mui/ml.Result at 09:40 am after dilution by 1/20 : > 30000 mui/ml.Result at 10:15 am after dilution by 1/50 : non valid (rfv=0).Result at 10:58 am after dilution by 1/25 : > 37500 mui/ml.Result at 10:58 am after dilution by 1/30 : > 45000 mui/ml.Result at 10:58 am after dilution by 1/40 : > 60000 mui/ml.It was reported that as a consequence of this issue, there were delayed results.The rfv 0 indicates a possible operator error like spr or strip missing.As a consequence to this issue, the customer had to send the sample to another laboratory to calculate the concentration and a delay in results of unspecified duration occurred.At the time of this assessment, there was no information about the patient or the context of the test, nor on any patient impact due to the delayed results.A biomérieux internal investigation will be initiated.Note: reference 30405 is not registered in the united states.The u.S similar device is product reference 30405-01 (k141133).

Manufacturer Narrative

A customer in spain notified biomérieux that they obtained invalid results leading to delayed results with a patient sample tested using vidas hcg 60 tests (ref.(b)(4), lot 1008714630, expiry date = 26-apr-2022).The customer indicated they were unable to calculate the real concentration of one patient sample.Investigation: there are no capas nor non-conformities linked with the issue reported by the customer.Reviewing the batch records for the customer¿s lot found no anomaly during the manufacturing, control and packaging processes for that lot.The complaint laboratory performed a control chart analysis using 4 internal samples, on 7 different batches of vidas hcg (ref (b)(4)) including customer's lot 1008714630.Hcg1: target 527 miu / ml.; ranges [414-640].Hcg13: target 856 miu / ml.; ranges [664-1048].Hcg15: target 1072 miu / ml.; ranges [824-1320].Hgc18: target 4.29 miu / ml.; ranges [1.84-6.74].All results were within specifications and the customer's lot results were consistent with the other lots.Investigator requested the customer send in the sample, but the customer confirmed that they did not have further material available to submit for testing.The complaint laboratory tested 4 internal samples (same above, target 527 - 856 - 1062 and 4.29 miu / ml) on retain kit from the reported lot.All internal sample results are within their expected specifications.The complaints laboratory tested a sample collected from a pregnant woman with different dilutions on retain kit.The dilutions are performed in cascade.Pure; > 1500.00 ui / l.1/20: 534.92 ui / l 10698.4 ui / l.1/40: 255.95 ui / l 10238.0 ui / l.1/80: 136.33 ui / l 10906.4 ui / l.1/160: 57.91 ui / l 9265.60 ui / l.All dilutions give a similar result.Conclusion: per the information above, no anomaly was highlighted with the analysis of quality data and the tests performed for internal samples on the retain kit vidas® hcg (ref (b)(4), lot 1008714630).The complaint laboratory has performed a serial dilutions of a sample of pregnant woman, in cascade.All results are similar.The complaints laboratory was unable to reproduce the issue observed by the customer and without the customer sample available, further investigation cannot be performed.According to the above data, vidas hcg ref (b)(4), lot 1008714630 is within the expected performance.

• 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
• MDR Report Key: 12346294
• MDR Text Key: 267501621
• Report Number: 8020790-2021-00178
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• PMA/PMN Number: K141133
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 10/15/2021

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: 04/26/2022
• Device Catalogue Number: 30405
• Device Lot Number: 1008714630
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/25/2021
• Initial Date FDA Received: 08/19/2021
• Supplement Dates Manufacturer Received: 09/17/2021
• Supplement Dates FDA Received: 10/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1