MAUDE Adverse Event Report: BIOMERIEUX, INC. VITEK® 2 GP TEST KIT

Catalog Number	21342
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
A customer in the united states reported misidentifications of streptococcus species for four (4) patient isolates in association with the vitek® 2 gp test kit (lot 2420749203).The customer reported that all four isolates were from small bowel brushings and the cultures were pure alpha hemolytic isolates.Isolate 1819805109: vitek 2 gp: streptococcus pseudoporcinus (95%); repeat: unidentified organism reference lab (b)(4) (b)(4): streptococcus mitis/oralis isolate 1820406366: vitek 2 gp: low discrimination streptococcus mitis/oralis; repeat 1: low discrimination streptococcus pseudoporcinus; repeat 2: low discrimination granulicatella adiacens reference lab (b)(4): streptococcus mitis/oralis isolate 1819208351: vitek 2 gp: streptococcus thoraltensis; repeat: streptococcus mitis/oralis.Isolate 1818304053: vitek 2 gp: streptococcus pseudoporcinus; repeat: streptococcus mitis/oralis.No patient information was provided by the customer.There is no indication or report from the hospital or treating physician to biomérieux that the discrepant result led to any adverse event related to the patient's state of health.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
An internal biomérieux investigation was performed with results as follows: the customer reported testing the isolates from tsab which had incubated for 18-24hrs at 35c.All set up parameters were within recommendations.The customer does not perform a saline sterility check and purchases pre-filled saline tubes from remel.Lab reports were submitted for the four (4) patient isolates as follows.Isolate 1819805109 had a screen shot of a maldi report submitted showing an identification of strep mitis/oralis.Two (2) gp lab reports were submitted.One showed a very good identification of strep.Pseudoporcinus with nine (9) atypical reactions (+: adh1, pyra and -: appa, leua, alaa, dgal, dmal, dmne, sac) for an identification of s.Mitis/oralis.The second lab report gave a result of unidentified and had five (5) atypical reactions (+: amy, dxyl, mbdg, sac and -: dgal) for an identification of s.Mitis/oralis.Isolate 1820406366 was reported by the customer to have been identified by maldi as s.Mitis/oralis but the second screen shot of maldi results that were provided did not match the isolate # (was labeled 18204063665).Four (4) gp lab reports were submitted.One showed a low discrimination call of s.Mitis/oralis, granulicatella adiacens & strep.Pseudoporcinus which is considered a correct call.Three (3) lab reports showed a low discrimination result of g.Adiacens and strep.Pseudoporcinus with five (5) atypical negative reactions (dgal, lac, dmal, dmne, sac) for an identification of s.Mitis/oralis.Isolate 1818304053 had four (4) gp lab reports submitted with one showing an excellent identification of strep.Parasanguinis, one report showing a low discrimination result of s.Mitis/oralis, strep.Pneumoniae and rothia dentocariosa and two (2) reports of either excellent or very good identifications of s.Mitis/oralis.Isolate 1819208351 had two (2) gp lab reports submitted.One lab report showed an excellent identification of strep.Thoraltensis and the other lab report showed an excellent identification of s.Mitis/oralis.Neither isolate had reference identification so an assessment of atypical reactions cannot be performed.Atypical reactions can indicate contamination, mixed culture, compromised viability of the strain, use of non-recommended media or other user set up errors or an atypical strain.However without the strains or raw data it's not possible to further evaluate the cause of the mis-identifications.Gp lot # 2420749203 and 2420732203 met final qc release criteria.These lots passed qc performance testing.

• Brand Name: VITEK® 2 GP TEST KIT
• Common Device Name: VITEK® 2 GP TEST KIT
• Manufacturer (Section D): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• MDR Report Key: 7837128
• Report Number: 1950204-2018-00319
• Device Sequence Number: 14065229
• Product Code: LQL
• UDI-Device Identifier: 03573026131920
• UDI-Public: 03573026131920
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: C1 EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2018

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 Expiration Date: 12/15/2019
• Device Catalogue Number: 21342
• Device Lot Number: 2420749203
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2018
• Supplement Date Received by Manufacturer: 10/18/2018
• Initial Report FDA Received Date: 08/31/2018
• Supplement Report FDA Received Date: 11/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1