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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® LYME IGM VIDAS LYME IGM 60 TESTS - 30319

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BIOMERIEUX SA VIDAS® LYME IGM VIDAS LYME IGM 60 TESTS - 30319 Back to Search Results
Catalog Number 30319
Device Problem Incorrect, Inadequate or Imprecise Resultor 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 false negative igm results in association with the vidas® lyme igm 60 tests (ref 30319, lot 1007297710) when testing a patient sample and comparing to the western blot igm results that obtained borderline positive results. The customer reported that the patient suspected he was bitten by a tick on (b)(6) 2019. The bite location was red and did not disappear for a few days. On (b)(6) 2019, the patient consulted his doctor and an antibiotic treatment was prescribed for 28 days. The doctor recommended to the patient to perform lyme testing six (6) weeks after the antibiotic treatment was started. On (b)(6) 2019, tests were performed with vidas lyme igm 60 tests, batch 1007297710, and the results were as follows: igm (tv
=
0. 01) : negative. Igg (tv
=
0. 02) : negative. It was mentioned by the customer that the calibrations were expired for these tests. A western blot test was also performed and the results were as follows: igm : positive (reported as borderline by the customer). Igg: negative. On (b)(6) 2019, the patient was tested again with the vidas lyme igm 60 tests, batch 1007297710 (correct calibration), and the results were as follows: igm (tv
=
0. 01) : negative. Igg (tv
=
0. 02) : negative. There is no indication or report from the laboratory that the false negative igm results led to any adverse event related to the patient's state of health. A biomérieux internal investigation will be initiated.
 
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Brand NameVIDAS® LYME IGM
Type of DeviceVIDAS LYME IGM 60 TESTS - 30319
Manufacturer (Section D)
BIOMERIEUX SA
chemin de l orme
marcy l etoile 69280
FR 69280
Manufacturer (Section G)
BIOMERIEUX SA
chemin de l orme
marcy l etoile 69280
FR 69280
Manufacturer Contact
candace martin
595 anglum road
hazelwood, MO 63042
MDR Report Key9433064
MDR Text Key219790503
Report Number8020790-2019-00071
Device Sequence Number1
Product Code LSR
Combination Product (y/n)N
Reporter Country CodePL
PMA/PMN Number
K122979
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/19/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/06/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/30/2020
Device Catalogue Number30319
Device Lot Number1007297710
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/18/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/25/2019
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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