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 Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

A customer in (b)(6) notified biomérieux of failing calibrations related to the vidas® hcg 60 tests (ref 30405, lot 1007904670).According to the package insert for the vidas® hcg kit, calibration using the calibrator provided in the kit, must be performed each time a new lot of reagents is opened, after the master lot data have been entered.Calibration should then be performed every 14 days.This operation provides instrument-specific calibration curves and compensates for possible minor variations in assay signal throughout the shelf-life of the kit.The customer stated that they initially obtained passing calibration results when the kit was first opened, but obtained out of range c1 control results while performing subsequent calibrations.Test 1: c1 = 38.21 miu/ml.Test 2: c1 = 38.66 miu/ml.Control c1 expected range: [18.71 ¿ 31.71] miu/ml.According to the package insert for the vidas® hcg kit, results cannot be validated if the control value deviates from the expected values.Since the customer was unable to obtain valid calibration results, no results for clinical samples can be expected to be produced.There is no indication or report from the customer that any erroneous results were obtained while testing patient samples or that any invalid results were reported to physicians.There is no indication or report from the customer that this event led to any adverse event related to any patient's state of health.However, the customer reported that the invalid calibration led to delayed results (duration = 2 days at a minimum) regarding three patient samples.A biomérieux internal investigation will be initiated.Note: vidas reference (b)(4) is not sold or distributed in the united states however, a similar reference is marketed in the united states under reference number (b)(4).

Manufacturer Narrative

Biomérieux completed an internal investigation in response to a customer compliant of failing calibrations for standard 1 in association with the vidas® hcg 60 tests (ref 30405, lot 1007904670).The customer stated the failing calibrations lead to delay of greater than two hours in reporting patient results.Biomérieux tested performed calibration tests using two customer returned standards and a biomérieux retain of lot 1007904670.Standard one was tested in duplicate along with control one for all three kits.All reagents tested complied with the mle data for 1007904670.Results are listed below: customer returned s1 calibration test first bottle: s1: 1072 rfv, range [964-1722] rfv.S1: 1027 rfv, range [964-1722] rfv.C1: 26.71 miu / ml, range [18.71-31.71] miu / ml.Customer returned s1 calibration test second bottle: s1: 1242 rfv, range [964-1722] rfv.S1: 1135 rfv, range [964-1722] rfv.C1: 21.68 miu / ml, range [18.71-31.71] miu / ml.Retained lot 1007904670 / 210209-0 s1 calibration: s1: 1222 rfv, range [964-1722] rfv.S1: 1202 rfv, range [964-1722] rfv.C1: 24.37 miu / ml, range [18.71-31.71] miu / ml.Biomérieux reviewed the manufacturing and quality data associated with lot 1007904670 and found no anomalies during the manufacturing control or packaging stages.The anomaly experienced by the customer was not reproduced, vidas® hcg lot 1007904670 conforms to its specifications.Refer to section h10.

• 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: 10557160
• MDR Text Key: 231259076
• Report Number: 8020790-2020-00088
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• PMA/PMN Number: K921302
• 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: 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/09/2021
• Device Catalogue Number: 30405
• Device Lot Number: 1007904670
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1