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U.S. Department of Health and Human Services

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

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BIOMERIEUX, SA VIDAS LYME IGM VIDAS® LYME IGM Back to Search Results
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.
 
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Brand NameVIDAS LYME IGM
Type of DeviceVIDAS® LYME IGM
Manufacturer (Section D)
BIOMERIEUX, SA
376 chemin de l orme
marcy l etoile 69280
FR 69280
MDR Report Key12129277
MDR Text Key281685199
Report Number8020790-2021-00156
Device Sequence Number1
Product Code LSR
Combination Product (y/n)N
PMA/PMN Number
K122979
Number of Events Reported1
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 Received07/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/21/2021
Device Catalogue Number30319
Device Lot Number1008490740
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/17/2021
Is This a Reprocessed and Reused Single-Use Device? No

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