MAUDE Adverse Event Report: BIOMERIEUX INC. VITEK® 2 GRAM POSITIVE ID TEST KIT; VITEK® 2 GP ID TEST KIT

Catalog Number	21342
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer from (b)(6) notified biomérieux of misidentification results when testing with the vitek® 2 gp id test kit.Vitek 2 obtained an identification of (b)(6).Three analysts at the customer site confirmed that the isolate was coagulase (b)(6).Therefore, the customer stated that the isolate would not be (b)(6).The customer is a pharmaceutical company, and they have stated that there is no patient associated with the tested isolate.As there is no patient associated with this strain, there is no adverse event related to any patient's state of health.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
A customer from (b)(6) had notified biomérieux of misidentification results when testing with the vitek® 2 gp id test kit.Vitek 2 obtained an identification of staphylococcus aureus.Three analysts at the customer site confirmed that the isolate was coagulase negative.Therefore, the customer stated that the isolate would not be staphylococcus aureus.An internal biomérieux investigation was performed.The strain was not available to submit for evaluation.The customer had tested the isolate from tryptic soy agar, loaded the cards within 30 minutes, and tested the correct mcfarland with a calibrated densichek plus.In addition, the customer reported that strain was grown at 33c.This temperature is not included in the gp culture requirements table, which states a temperature range of 35 °c to 37 °c.Strains that are tested outside of the recommended culture requirements may give atypical results.The strain was identified as coagulase negative staphylococci by a negative coagulase test.The lab report showed a 95% staphylococcus aureus identification with nine (9) atypical reactions according to the gp knowledge base for an identification of coagulase negative staphylococcus.(eight (8) were atypical positive: drib, novo, dman, nag, pyra, mbdg, dtre, aglu, and one (1) was atypical negative: ure).Atypical positive reactions can indicate contamination, mixed culture, other user set up errors or an atypical strain.However, without the strain or raw data, it is not possible to further evaluate the cause of the misidentification.Vitek 2 gp lot # 2420591103 met final qc release criteria.This lot passed qc performance testing.

• Brand Name: VITEK® 2 GRAM POSITIVE ID TEST KIT
• Common Device Name: VITEK® 2 GP ID TEST KIT
• Manufacturer (Section D): BIOMERIEUX INC.; 595 anglum road; saint louis MO 63042
• MDR Report Key: 7703107
• Report Number: 1950204-2018-00265
• Device Sequence Number: 2580218
• Product Code: LQL
• UDI-Device Identifier: 03573026131920
• UDI-Public: 03573026131920
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: C1 EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2018

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: 07/10/2019
• Device Catalogue Number: 21342
• Device Lot Number: 2420591103
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2018
• Supplement Date Received by Manufacturer: 09/04/2018
• Initial Report FDA Received Date: 07/19/2018
• Supplement Report FDA Received Date: 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1