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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMERIEUX, SA API® 20 E 25 STRIPS

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BIOMERIEUX, SA API® 20 E 25 STRIPS Back to Search Results
Catalog Number 20100
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Event Description
A customer in (b)(6) notified biomérieux of false positive citrate results for escherichia coli (e. Coli) atcc® 25922 in association with api® 20 e 25 strips (ref. 20100, lot 1006601250). The customer performed testing four (4) times using api® 20 e 25strips lot 1006601250 with two (2) strains of e. Coli atcc® 25922 and obtained a positive result for all assays. E. Coli atcc® 25922 was also tested in parallel using api® 20 e 25strips lot 1006611730, and obtained a negative citrate result. The customer confirmed the expected citrate result for e. Coli atcc® 25922 is negative. As there is no patient associated with this quality control strain, there is no adverse event related to any patient's state of health. Biomérieux will initiate an internal investigation.
 
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Brand NameAPI® 20 E 25 STRIPS
Type of DeviceAPI® 20 E 25 STRIPS
Manufacturer (Section D)
BIOMERIEUX, SA
3 route de port michaud
la balme, 38390
FR 38390
Manufacturer (Section G)
BIOMERIEUX, SA
3 route de port michaud
la balme, 38390
FR 38390
Manufacturer Contact
candace martin
595 anglum road
hazelwood, MO 63042
3145068201
MDR Report Key9293357
MDR Text Key220259870
Report Number9615754-2019-00116
Device Sequence Number1
Product Code JTO
UDI-Device Identifier03573026047818
UDI-Public03573026047818
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
C1 EXEMPT
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 01/02/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/07/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/11/2019
Device Catalogue Number20100
Device Lot Number1006601250
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 Received12/06/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/22/2018
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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