MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® HCG

Catalog Number 30405

Device Problem False Positive Result (1227)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

A customer in (b)(6) notified biomérieux of discrepant results associated with vidas® hcg (reference 30405).The customer reported during a reference test that the eqa 17md10 result reported out of ranges; too high.Eqa 17md10 pbq, hcg batch 180331-0 / 1005624740, date of the analysis: 10/10/2017, value: 2085 rfv 666.89ui / l / high.Peer group: number: 38, target: 546.3 iu / l, acceptable limits: 4464.4-628.Calculation of acceptable limits +/- robust statistical pbqs, cv: 9.6%, note: +1, z score: 2.3, instrument: mini vidas, qcv: ok 02/10/2017 and 30/10/2017.The anomaly occurs: in use of the hcg kit.Calibration 2/10, s1: 1119/1172 rfv 874 - 1560, c1: 84 rfv 23.76miu / ml 17.51 - 29.93, ciq for this parameter: no.Pre-analysis vidas®: calibration: reconstitution osmosis water used / homogenization 10/20 times reversals / conservation freezing.Reagent temperature reset: yes.Volume of test : 100[?]l.The second eqa is ok: 17md09, result: 16 rfv 5.57 ui / l, target: 4.48 iu / l, acceptable limits: 2.91-6.05.Calculation of acceptable limits +/- robust statistical pbqs, cv: 12.9%, note: b +, z score: 1.9.There is no patient associated with this quality control test.An internal biomérieux investigation will be initiated.

Manufacturer Narrative

An internal biomérieux investigation was performed.The customer complained about external quality control 17md10 from probioqual (french eqa provider) found out of acceptable limits using vidas® hcg batch 1005624740 / 180331-0.The analysis of the batch history records vidas hcg batch 1005624740 / 180331-0 showed no anomaly during the manufacturing and control processes.The complaint laboratory tested three (3) internal samples (target: ( hcg1: 527ui/ml; hcg20: 551 ui/ml; hcg32: 657ui/ml) on the retain kit vidas hcg batch 1005624740 / 180331-0 (lot used by the customer) and on vidas hcg lot 180830-0/1005960160 (lot used by quality product for the control testing).The results obtained were within the expected specifications and similar to those obtained during release.There is no drift of vidas hcg batch 1005624740 / 180331-0 since its release.Result obtained by complaint laboratory for pbq 17md10 is similar to those obtained initially (there is no stability issue for pbq 17md10).As the s1 signal obtained by customer is a little bit lower than those obtained by the complaint laboratory, we can suspect a lack of homogenization at customer level.Indeed, it is recognized that a bad homogenization of s1 or sample could lead to a bad signal level.If eqa is not used with a good volume, an inferior volume could lead to higher result.Final conclusion: according to all of the data mentioned above, vidas hcg lot 180830-0/1005960160 is within the expected specifications.

• Brand Name: VIDAS® HCG
• Type of Device: VIDAS® HCG
• Manufacturer (Section D): BIOMERIEUX SA; chemin de l orme; marcy l etoile, rhone 69280; FR
• MDR Report Key: 7111975
• MDR Text Key: 96022261
• Report Number: 3002769706-2017-00401
• 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: 02/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Catalogue Number: 30405
• Device Lot Number: 1005624740
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1