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

Catalog Number 32600

Device Problem Incorrect, Inadequate or Imprecise Result or 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.

• Brand Name: API RAPID ID 32 STREP 25STRIPS
• Type of Device: API® 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 Key: 11532107
• MDR Text Key: 272503090
• Report Number: 9615754-2021-00033
• Device Sequence Number: 1
• Product Code: JTO
• UDI-Device Identifier: 03573026066536
• UDI-Public: 03573026066536
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: C1 EXEMPT
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2021
• Device Catalogue Number: 32600
• Device Lot Number: 1008262780
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1