MAUDE Adverse Event Report: BIOMERIEUX,SA VIDAS® HCG

Catalog Number 30405

Device Problems False Negative Result (1225); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Misdiagnosis (2159)

Event Type  Injury  

Event Description

A customer in (b)(6) notified biomérieux of a false negative hcg result in association with vidas® hcg 60 tests (reference 30405, batch 1006940840).Vidas reference 30405 is not sold or distributed in the united states however, a similar instrument is marketed in the united states under reference number 30405-01.The customer stated support medication was withdrawn after obtaining the initial hcg negative result and negative ultrasound.After starting ovarian stimulation, an echograph was performed and a possible gestation sac was observed.The hcg test was repeated and yielded a result of 5000 miu/ml.The customer recovered the previous serum that was negative and they obtained a result of 212 miu/ml.After several ultrasound scans, it was found that the pregnancy was not evolutionary and was diagnosed as a clinical abortion.Although there is no indication or report from the laboratory that the discrepant result led to any direct negative impact to the patient's state of health, the treating physician decided to withdraw medication after the discrepant vidas hcg and ultrasound results.Biomérieux will initiate an internal investigation.

Manufacturer Narrative

An internal investigation was performed for a customer in spain reporting a false negative hcg result in association with vidas® hcg 60 tests (reference 30405, batch 1006940840).The customer stated the negative result was not reproduced.Customer's results : on (b)(6) 2019 : sample id (b)(6): -3 rfv < 2miu/ml - negative interpretation on (b)(6) 2019 : same sample id (b)(6): 701 rfv 212.33 miu/ml - positive interpretation, repetition of the test (same day with same sample): 727 rfv , 220.76 miu/ml - positive interpretation.Customer's material: no customer's material was received for investigation.Quality control records: no capa nor non conformity was linked to the customer's issue recorded on vidas hcg reference 30405 lot 1006940840 / 191109-0.Analysis of the batch history records showed no anomaly during the manufacturing, control and packaging processes on lot vidas hcg reference 30405 lot 1006940840 / 191109-0.Study of internal samples control charts : complaint laboratory observed 4 internal sera (targets 231 - 131 - 316 - 205 mui/ml) on 10 lots of vidas hcg including customer's lot (191109-0).All results were within specifications and customer's lot was in the trend of the other lots.Complaint analysis : no other complaint was registered for a similar issue on vidas hcg reference 30405 lot 1006940840 / 191109-0.Tests performed: complaint laboratory tested 3 internal samples (targets 231 - 131 - 316 mui/ml) on retain kit vidas hcg reference 30405 lot 1006940840 / 191109-0.Results were within specifications and close to the values obtained before batch release.There was no drift of the batch since its release.Complaint laboratory performed a test without receptacle and another test without sample to simulate operator error, and reproduced the customer result at 2

• 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: 8705305
• MDR Text Key: 148213312
• Report Number: 8020790-2019-00034
• 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: 09/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 30405
• Device Lot Number: 1006940840
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other