MAUDE Adverse Event Report: BIOMÉRIEUX, SA VIDAS RUB IGG II 60 TESTS - 30221

Catalog Number 30221

Device Problem False Positive Result (1227)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/08/2020

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

A customer from (b)(6) reported to biomérieux that they observed false positive results for a patient tested with vidas rub igg ii 60 tests (ref.30221, lot 1007673260, expiry date 10-oct-2020).The customer obtained the following results for a patient¿s sample tested with vidas rub igg ii 60 tests, lot 1007673260 on 08-feb-2020: initial testing result = 46 iu/ml (positive); re-testing result = 59 iu/ml (positive).Testing of the patient¿s sample via alternate methods provided the following results: architect abbott results = 0.00 iu/ml (negative) and 0.4 iu/ml (negative); with chimiluminescence technic, liaison diasorin result: < 3 iu/ml (< 7 iu/ml: negative).The customer indicated that correct "negative" results were communicated to the physician.There is no evidence of any adverse health outcome for the patient related to this issue.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

This report was initially submitted following notification from a customer in france regarding false positive results for a patient tested with vidas rub igg ii 60 tests (ref.(b)(4) lot 1007673260).A biomérieux internal investigation has been completed with the following results: no capa or non-compliance related to the reason for the complaint.According to the analysis of the quality data, no anomalies during the manufacturing, control and packaging stages, in connection with the reason for the complaint.Observation of four (4) internal samples on five (5) lots of vidas rub gii, including the client lot revealed the customer's lot is in the trend of the other lots.The results obtained for calibration and controls are in accordance with the mle data for the customer's lot.Negative internal samples test results obtained for the calibration and the controls conform to the mle data.The results obtained conform to the expected standards.However, there is a negative shift in results towards high standards.The sample was returned and tested with customer lot and two other lots.The positive result was confirmed on the three (3) reagent lots, however the results varied.A dilution test was performed on the customer lot and there was no evidence of interference.A test was performed by biomnis and confirmed the results obtained by the customer with the same technique and made it possible to rule out a tube error.The vidas rubg ii (ref: (b)(4) lot: 1007673260 / 201010-0) still complied with its specifications.The anomaly encountered by the client was related to the sample.The absolute cause of this false positive result is not clear.

• Brand Name: VIDAS RUB IGG II 60 TESTS - 30221
• Type of Device: VIDAS RUB IGG II 60 TESTS - 30221
• Manufacturer (Section D): BIOMÉRIEUX, SA; chemin de l orme; marcy l etoile 69280 ; FR 69280
• MDR Report Key: 9856829
• MDR Text Key: 207754063
• Report Number: 8020790-2020-00033
• Device Sequence Number: 1
• Product Code: LFX
• 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: 05/28/2020

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: 10/10/2020
• Device Catalogue Number: 30221
• Device Lot Number: 1007673260
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/18/2020
• Initial Date FDA Received: 03/19/2020
• Supplement Dates Manufacturer Received: 05/13/2020
• Supplement Dates FDA Received: 05/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1