MAUDE Adverse Event Report: BIOMERIEUX, SA API ID 32 C; ID 32 C 25STRIPS+25MEDIA

Model Number	32200
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
An internal complaint was initiated following a review of a 2019 scientific publication entitled, "identification and antifungal susceptibility profiles of kodamaea ohmeri based on a seven-year multicenter surveillance study" by zhou m, et al.The publication noted two (2) misidentifications of kodamaea ohmeri in association with the api® id 32 c.Specific lot numbers used during the study were not disclosed.This publication compares identification methods for accuracy in identifying kodamaea ohmeri.The 62 patient strains of kodamaea ohmeri used in this study were collected from 24 hospitals in china over a seven year period.The strains were verified to be kodamaea ohmeri by 26s rdna sequencing.The original identification methods used and results obtained by the different hospitals were compared to the expected identification.Six (6) of the 62 strains were originally identified using the atb 32 c with two (2) misidentifications.Four (4) of the strains were correctly identified as kodamaea ohmeri.Atb 32 c misidentifications.1 x candida glabrata.1 x candida albicans.Based on the information provided, there is no indication that the discrepant results led to any adverse event related to the patient's state of health.An internal biomérieux investigation will be initiated.
Additional Manufacturer Narrative
This report was initially submitted following initiation of an internal complaint regarding review of a 2019 scientific publication entitled, "identification and antifungal susceptibility profiles of kodamaea ohmeri based on a seven-year multicenter surveillance study" by zhou m, et al.The publication noted two (2) misidentifications of kodamaea ohmeri in association with the api® id 32 c.Specific lot numbers used during the study were not disclosed.A biomérieux internal investigation has been completed with the following results: a performance analysis was performed using a panel of 20 internal kodamaea ohmeri (k.Ohmeri) strains.The strains were tested with id 32 c product (reference 32200.The quality control (qc) tests were performed with atcc strains mentioned in the package insert: product id 32 c , reference 32200: - cryptococcus humicola atcc 64676, - candida glabrata atcc 64677.Mass spectrometry was used as reference methodology.The 20 strains of the panel were identified in parallel with vitek ms v3 (knowledge v3.2) to check the intended result.All the results obtained were in agreement with the quality control specifications for all the qc strains tested.The 20 strains of the panel were tested with id 32 c product (lot number 1007970280 exp 19mar2021).The following results were obtained: good identification to k.Ohmeri obtained for s20.Very good identification to k.Ohmeri obtained for s6, s8, s9, s12, s13, s16.Excellent identification to k.Ohmeri obtained for all the other 13 strains.The vitek ms methodology confirmed the identification to the species k.Ohmeri as expected.As a conclusion, no misidentifications were obtained for the 20 strains of k.Ohmeri tested with id 32c strips.The performance study performed with a panel of 20 internal strains of kodamaea ohmeri with product id 32 c showed that there was no drift in the performance.

• Brand Name: API ID 32 C
• Common Device Name: ID 32 C 25STRIPS+25MEDIA
• Manufacturer (Section D): BIOMERIEUX, SA; 3 route de port michaud; la balme, 38390 ; FR 38390
• MDR Report Key: 9205113
• Report Number: 9615754-2019-00106
• Device Sequence Number: 19480368
• Product Code: JXB
• UDI-Device Identifier: 03573026066383
• UDI-Public: 03573026066383
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,l
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2021

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
• Operator of Device: Health Professional
• Device Model Number: 32200
• Device Catalogue Number: 32200
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2019
• Supplement Date Received by Manufacturer: 02/09/2021
• Initial Report FDA Received Date: 10/17/2019
• Supplement Report FDA Received Date: 03/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1