MAUDE Adverse Event Report: GENMARK DIAGNOSTICS, INC. BLOOD CULTURE IDENTIFICATION GRAM-POSITIVE (BCID-GP); GRAM-POSITIVE BACTERIA AND THEIR RESISTANCE MARKERS

Catalog Number 09556508001

Device Problem False Negative Result (1225)

Patient Problem Unspecified Infection (1930)

Event Date 10/07/2022

Event Type  Death  

Event Description

On november 1, 2022, genmark was advised of unexpected negative results for staphylococcus aureus on the eplex bcid-gp panel tested on (b)(6) 2022, where the eplex bcid-gp panel detected an unspeciated staphylococcus result.Culture performed on (b)(6) 2022 identified staphylococcus aureus.On november 3, 2022, during communication related to the investigation, genmark was advised that the patient associated with the result was deceased on (b)(6) 2022.Genmark was advised the eplex bcid-gp results were not reported to the physician; however, the customer declined to comment further on the impact of the eplex bcid-gp results.On november 29, 2022, the customer indicated that they would not provide any further information on the matter.Data was analyzed per internal procedures and confirmed robust internal controls were generated for the eplex bcid-gp run suggesting the consumable performed as expected.Review of the eplex gp panel test run information for this sample shows robust signal for staphylococcus and low level signal that did not breach threshold for staphylococcus aureus.This suggests the test performed as described in the package insert, where it indicates, the eplex bcid-gp panel staphylococcus result is based on four assays: the species-specific staphylococcus aureus, staphylococcus epidermidis and staphylococcus lugdunensis assays and a broad staphylococcus assay.The broad staphylococcus assay will detect each of the species targeted by the species-specific assays, but its primary purpose is to detect other staphylococcus species.If all four assays are negative, the staphylococcus result will be ¿not detected¿.If any of the four assays is positive, the staphylococcus result will be ¿detected¿.If only the staphylococcus assay is positive, an unspeciated staphylococcus has been detected.

Manufacturer Narrative

Analysis: internal review of qc release data for affected lot 91292929 confirms the consumable lot successfully met the established qc release specifications.Review of the eplex bcid-gp panel test run information demonstrates that the internal controls were valid.No run malfunction was observed and the eplex instrument (serial # (b)(4)) was working within design specifications.Conclusion: while a discrepant result was reported by the customer, no quality and/or performance issues have been identified for the affected eplex bcid-gp panel lot.Genmark¿s investigation suggests the panel functioned as intended, and in accordance with the genus and group target results interpretation described in the package insert.The eplex bcid-gp panel was appropriately used according to the product's intended use, which describes the assay as an aid in the diagnosis of bloodstream infection when used in conjunction with other clinical information.The results from the eplex bcid-gp panel are intended to be interpreted in conjunction with gram stain results and should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.

• Brand Name: BLOOD CULTURE IDENTIFICATION GRAM-POSITIVE (BCID-GP)
• Type of Device: GRAM-POSITIVE BACTERIA AND THEIR RESISTANCE MARKERS
• Manufacturer (Section D): GENMARK DIAGNOSTICS, INC.; 5964 la place ct, suite 100; carlsbad CA 92008
• Manufacturer Contact: alan maderazo ; 5964 la place ct, suite 100; na; carlsbad, CA 92008 ; 7604484308
• MDR Report Key: 15900949
• MDR Text Key: 304678453
• Report Number: 3008632402-2022-00075
• Device Sequence Number: 1
• Product Code: PAM
• UDI-Device Identifier: 00857167005320
• UDI-Public: 00857167005320
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181663
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/19/2023
• Device Catalogue Number: 09556508001
• Device Lot Number: 91292929
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2022
• Initial Date FDA Received: 12/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 61 YR
• Patient Sex: Male