MAUDE Adverse Event Report: BIOMERIEUX, SA API ID 32 E 25 STRIPS; API® ID 32 E 25 STRIPS

Catalog Number 32400

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

An industry customer from (b)(6) notified biomérieux of an incorrect identification profile when testing an environmental swab with the api® id 32 e 25strips (ref.32400, lot 1007771380) used in conjunction with api® web.The customer cultured the organism on tryptic soy agar then repeated testing using api® id 32 e 25strips and the maldi-tof test method.Repeat testing with the api® id 32 e 25strips obtained the same incorrect identification profile, the maldi-tof test method identified the organism as cronobacter sakazakii.The api® 32 data base technical brochure includes api® id 32 e 25strips for identification of cronobacter sakazakii.However, biomérieux customer service recommended use of the api® 20e strip to test the industry isolate as more cronobacter species can be detected.As there is no patient associated with this industry strain, there is no adverse event related to any patient's state of health.Note: the product reference 32400 is not registered in the united states.The u.S.Similar device is product reference 20100.Biomérieux will initiate an internal investigation.

Manufacturer Narrative

This report was initially submitted following notification from a customer in new zealand regarding an incorrect identification profile when testing an environmental swab with the api® id 32 e 25strips (ref.32400, lot 1007771380) used in conjunction with api® web.The customer obtained an unacceptable profile when testing a cronobacter spp strain.A review of all data registered for the manufacturing and control departments of lot 1007771380 did not highlight any event that could have led to the identification error.Likewise, a review of all complaints did not show any problem on this lot.The retained samples for the impacted lot (1007771380) were tested in parallel with an internal lot number (1007955430) used as a reference lot.The customer¿s strain was unable to be submitted to biomérieux.The investigation was performed using the atcc® quality control strains mentioned in the id 32 e package insert (escherichia coli atcc® 11775¿, salmonella spp atcc® 35664¿, raoultella ornithinolytica atcc® 31898¿ and stenotrophomonas maltophilia atcc® 51331¿).The results were all in compliance with the expected specifications.The customer¿s positive control (cronobacter sakazakii) gave a good identification on id 32 e product because this species is included in the id 32 e database, whereas cronobacter spp is not included.Biomérieux recommended to the customer the use of api® 20 e product (reference 20100) to realize cronobacter spp identification.

• Brand Name: API ID 32 E 25 STRIPS
• Type of Device: API® ID 32 E 25 STRIPS
• Manufacturer (Section D): BIOMERIEUX, SA; 3 route de port michaud; la balme 38390 ; FR 38390
• MDR Report Key: 10260975
• MDR Text Key: 221808433
• Report Number: 9615754-2020-00114
• Device Sequence Number: 1
• Product Code: JSS
• Combination Product (y/n): N
• PMA/PMN Number: C1 EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/05/2020
• Device Catalogue Number: 32400
• Device Lot Number: 1007771380
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/10/2020
• Initial Date FDA Received: 07/10/2020
• Supplement Dates Manufacturer Received: 08/07/2020
• Supplement Dates FDA Received: 08/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1