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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMÉRIEUX, SA API RAPID ID 32 STREP 25STRIPS API® RAPID ID 32 STREP 25STRIPS

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BIOMÉRIEUX, SA API RAPID ID 32 STREP 25STRIPS API® RAPID ID 32 STREP 25STRIPS Back to Search Results
Catalog Number 32600
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
A biomérieux internal investigation has been completed with the following results: the customer strain was requested but it was not possible for the customer to return the strain. An analysis of the batch history record of api® rapid id 32 strep 25strips (reference (b)(4), lot 1008262780) showed no anomaly during the manufacturing and quality control processes. Retained samples analysis: the retained samples for the impacted api® rapid id 32 strep 25strips (reference (b)(4), lot 1008262780) were tested in parallel with api® rapid id 32 strep 25strips (reference (b)(4), lot 1008190290). The investigation was performed using the three atcc® quality control strains mentioned in the rapid id 32 strep package insert : streptococcus equi ssp equi atcc® 33398¿, streptococcus agalactiae atcc® 12401¿ and streptococcus vestibularis atcc® 49124¿. One identification strip was tested per lot and per strain. All profiles obtained conformed to the expected results for the three strains tested and on both lots of rapid id 32 strep strips. The quality of the reported lot remains within specifications. Database analysis: an analysis of the database (rapid id 32 strep v4. 0) was done to compare streptococcus uberis and streptococcus oralis profiles. The following tests are discriminants for identification to streptococcus uberis and streptococcus oralis: rib (ribose), man (mannitol), sor (sorbitol), mbdg (methyl-bd glucopyranoside), adh (arginine dihydrolase) and bglu (b glucosidase). All these tests are expected to be positive for stretococcus uberis. The details of the results the customer obtained were not received; however, if those tests obtained negative results it could be due to the viability of the strain. As indicated in the instructions for use, it is recommended to ¿pick up a well-isolated colony and make a subculture on columbia sheep blood agar (with or without colistin / nalidixic acid). ¿, and ¿incubate for 18-24 hours at 37°c in aerobic or anaerobic conditions depending on the optimal growth conditions of the organism. ¿ the investigation results did not identify any product performance issues.
 
Event Description
A veterinary customer in (b)(6) notified biomérieux of obtaining a misidentification of a known strain of streptococcus uberis obtained as streptococcus oralis while using the api® rapid id 32 strep 25 strips (reference # 32600, lot # 1008262780). The test was repeated four (4) times with the same strain by two different technicians. Each time, streptococcus oralis has been identified instead of streptococcus uberis. The customer did not perform qc strain testing as recommended by the package insert. It is not known if the customer used a patient strain or a quality control strain. The customer confirmed that there was no patient impact. Local customer service (lcs) called the customer to obtain additional information and the customer stated they retested and the strips are now working.
 
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Brand NameAPI RAPID ID 32 STREP 25STRIPS
Type of DeviceAPI® RAPID ID 32 STREP 25STRIPS
Manufacturer (Section D)
BIOMÉRIEUX, SA
3 route de port michaud
la balme 38390
FR 38390
Manufacturer (Section G)
BIOMÉRIEUX, SA
3 route de port michaud
la balme 38390
FR 38390
Manufacturer Contact
danielle cooper
595 anglum road
hazelwood, MO 63042
MDR Report Key11532107
MDR Text Key272503090
Report Number9615754-2021-00033
Device Sequence Number1
Product Code JTO
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
Report Date 03/19/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/28/2021
Device Catalogue Number32600
Device Lot Number1008262780
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 Received02/19/2021
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

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