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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMERIEUX SA ETEST® DAPTOMYCIN DPC 256 WW S30

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BIOMERIEUX SA ETEST® DAPTOMYCIN DPC 256 WW S30 Back to Search Results
Catalog Number 412324
Device Problem Incorrect Or Inadequate Test Results (2456)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
A customer from (b)(6) reported out of range low results for internal quality controls (qc) in association with etest® daptomycin dpc 256 ww s30 (ref 412324) lot 1005932460. The customer stated that when their qc is within range it is always at the very lowest end of the qc range for both the staphylococcus aureus atcc® 29213 and enterococcus faecalis atcc® 29212. The customer reported that when the qc is out of range, it is always lower than expected. The customer reported that results were delayed at least 72 hours for two (2) patients (with vre in the blood) due to the daptomycin qc failing at least twice. There is no indication or report from the hospital or treating physician to biomérieux that the discrepant result led to any adverse event related to a patient's state of health. A biomérieux internal investigation will be initiated. Reference 412324, etest® daptomycin dpc 256 ww s30, is not approved in the united states, however, the equivalent product, reference 412323 etest® daptomycin dpc 256 ww s30 is approved.
 
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Brand NameETEST® DAPTOMYCIN DPC 256 WW S30
Type of DeviceETEST® DAPTOMYCIN DPC 256 WW S30
Manufacturer (Section D)
BIOMERIEUX SA
3 route de port michaud
la balme les grottes isere 383
FR
Manufacturer (Section G)
BIOMERIEUX SA
3 route de port michaud
la balme les grottes isere 383
FR
Manufacturer Contact
debra broyles
595 anglum road
hazelwood, MO 63042
3147317301
MDR Report Key7541768
MDR Text Key109636811
Report Number3002769706-2018-00068
Device Sequence Number1
Product Code JWY
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K042392
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/26/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/24/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/30/2020
Device Catalogue Number412324
Device Lot Number1005932460
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/05/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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