MAUDE Adverse Event Report: BIOMERIEUX, SA API 20 STREP STRIPS; API® 20 STREP STRIPS

Model Number 20600

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 biomerieux of incorrect well reactions for hippuric acid (hip), beta-galactosidase (bgal), and peptidoglycan-associated lipoprotein (pal) for an external qc streptococcus dysgalactiae strain using api 20 strep 25strips+25media strips (reference (b)(4)).The results the customer obtained were consistent with aerococcus urinae not streptococcus dysgalactiae.Biomerieux customer service requested additional information about this event including lot number and sample preparation technique.Additionally, customer service recommended to perform qc tested using isolates that are listed in the api 20 strep 25strips+25media package insert.At the time of this assessment no additional information has been provided as there is no patient associated with this quality control strain, there is no adverse event related to any patient's state of health.Biomerieux will initiate an internal investigation.

Manufacturer Narrative

An investigation was initiated in response to a customer complaint of incorrect well reactions for hippuric acid (hip), beta-galactosidase (bgal), and peptidoglycan-associated lipoprotein (pal) for an external qc streptococcus dysgalactiae strain using api® 20 strep 25strips+25media strips (reference 20600).Retained samples analysis: the customer did not disclose which lot of api® 20 strep 25strips+25media strips was used, so two (2) random lots were tested: lot number 1007445940, expiry date 26-jun-2020, and lot number 1007664770 expiry date 06-oct-2020.Compliance with our specifications has been checked with the following atcc quality control strains which are also tested to release api® 20 strep strips: streptococcus equi spp zooepidemicus atcc 700400.Streptococcus uberis atcc 700407.The api® 20 strep performance of bot lots comply with the specifications.Analysis of provided strain: the identification of the supplied organism has been confirmed in-house with vitek ms kb v3.2 and a low discrimination between streptococcus dysgalactiae ssp equisimilis 50% and streptococcus dysgalactiae ssp dysgalactiae 50% was obtained.Note: it is known that vitek ms cannot differentiate these 2 subspecies.The customer's strain was tested on the 2 random lots of api® 20 strep strips (lot number 1007445940 and lot number 1007664770).The hip test was negative after 4 hours of incubation time on the two lots.The identification obtained on api® 20 strep strips, is streptococcus dysgalactiae ssp equisimilis with both lots tested in-house (94,8% after 24 hours of incubation time).Complaint trend analysis: complaint trending analysis was performed for reference 20600 since january 2015 and no other complaints have been recorded for hip false positive.Conclusion: the customer's false positive hip test and the misidentification as aerococcus urinae were not reproduced internally.The identification obtained on api® 20 strep strip is streptococcus dysgalactiae ssp equisimilis.Note : this subspecies "equisimilis" is very close to the intended identification by the survey "streptococcus dysagalactiae ssp dysgalactiae".The trend analysis of the complaints does not show any deviation on the product api® 20 strep , reference 20600.As a conclusion, the performance of api® 20 strep strip is within specifications and as the investigation did not identify any product performance issue.

• Brand Name: API 20 STREP STRIPS
• Type of Device: API® 20 STREP STRIPS
• Manufacturer (Section D): BIOMERIEUX, SA; 3 route de port michaud; la balme, 38390 ; FR 38390
• MDR Report Key: 9296602
• MDR Text Key: 219765298
• Report Number: 9615754-2019-00118
• Device Sequence Number: 1
• Product Code: JTO
• UDI-Device Identifier: 03573026048440
• UDI-Public: 03573026048440
• 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: 07/09/2020

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 Model Number: 20600
• Device Catalogue Number: 20600
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/09/2019
• Initial Date FDA Received: 11/08/2019
• Supplement Dates Manufacturer Received: 06/09/2020
• Supplement Dates FDA Received: 07/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1