MAUDE Adverse Event Report: BIOMERIEUX, SA VIDAS LYME IGM VIDAS® LYME IGM

Catalog Number 30319

Device Problem False Negative Result (1225)

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

Event Type  malfunction  

Event Description

On 08-jun-2021, a customer from (b)(6) reported to biomérieux that they observed discrepant results (false negative) when testing two patient serum samples with vidas® lyme igm 60 tests (ref 30319, batch 1008490740, expiry date 21-dec-2021) compared to other methods. The clinical context for both patients was not reported. The first line of screening was done on triturus analyser (lyme igm) and gave a high positive result (ratio 4. 37 for one patient and >5. 4 for the other). Then, a confirmation test was performed on (b)(6) 2021 using vidas lyme igm 60 tests (batch 1008490740 and the results were negative: - patient n°(b)(6): tv
=
0. 06, - patient n° (b)(6): tv
=
0. 13. These results were obtained after a valid calibration performed on (b)(6) 2021 : - s1 rfv results: 2429 - 2412 (acceptable range [1172-2538), - c1 rfv
=
1829, tv
=
0. 75 (positive), - c2 rfv
=
-2 rfv, tv
=
0. 00 (negative). The s1 results were within the acceptable range but close to the upper limit. The customer did not use a vortex in the calibration steps but instead homogenization by numerous manual reversals. Since the values on triturus analyzer were high, western blot was performed and was positive for both patients showing presence of antibodies against ospc antigens. Igg test with elisa technique was negative for both patients. At the time of reporting, there is no indication or report from the laboratory that the discrepant result led to any adverse event related to the patient's state of health. A biomérieux internal investigation has been initiated. Note ref. 30319 is not registered in the united state; the similar device is ref. 416436.

• Brand Name: VIDAS LYME IGM
• Type of Device: VIDAS® LYME IGM
• Manufacturer (Section D): BIOMERIEUX, SA; 376 chemin de l orme; marcy l etoile 69280 ; FR 69280
• MDR Report Key: 12129277
• MDR Text Key: 281685199
• Report Number: 8020790-2021-00156
• Device Sequence Number: 1
• Product Code: LSR
• Combination Product (y/n): N
• PMA/PMN Number: K122979
• 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

0 Patients were Involved in the Event:

• Date FDA Received: 07/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 12/21/2021
• Device Catalogue Number: 30319
• Device Lot Number: 1008490740
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No