MAUDE Adverse Event Report: GENMARK DIAGNOSTICS, INC. EPLEX BLOOD CULTURE IDENTIFICATION GRAM NEGATIVE (BCID-GN) PANEL; GRAM-NEGATIVE BACTERIA AND ASSOCIATED RESISTANCE MARKERS

Catalog Number	09556494001
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	07/20/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
Analysis: internal review of qc release data for affected lot 91246383 confirms the consumable lot successfully met the established qc release specifications.Review of the eplex bcid-gn panel test run information demonstrates that the internal controls were valid.No run malfunction was observed and the eplex instrument (serial #1922100442) 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-gn panel lot.Genmark¿s investigation is ongoing, as the sample has been requested from the customer.The eplex bcid-gn 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-gn 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.
Event or Problem Description
On (b)(6) 2022, genmark was advised of unexpected negative results for pseudomonas aeruginosa on the eplex bcid-gn panel tested on (b)(6) 2022.On (b)(6) 2022, during communication related to the investigation genmark was advised that patient was deceased.The customer was not able to confirm whether the result of the eplex contributed to the death of the patient and referred to the patient history of liver failure and previous admissions for pseudomonas cholangitis/sepsis.Genmark was advised that the patient had been on 2 grams of iv meropenem every 12 hours for two weeks prior to being admission on (b)(6) 2022 with weakness, fevers, and chills.Background: an initial set of blood culture bottles collected on (b)(6) 2022 was not tested on eplex and showed only stenotrophomonas growing in culture.A second set of blood culture bottles were collected on (b)(6) 2022 and this time stenotrophomonas and pseudomonas were seen in culture.An aliquot from this set of blood culture bottles was tested with the eplex bcid-gn on (b)(6) 2022 where only stenotrophomonas maltophilia was detected.Testing a second aliquot from the same bottle with the eplex bcid-gn again resulted in only stenotrophomonas maltophilia being detected.A third set of blood culture bottles were collected on (b)(6) 2022 and only stenotrophomonas was seen in culture.Data was analyzed per internal procedures and confirmed robust internal controls were generated for both eplex bcid-gn runs suggesting the consumables performed as expected.

• Brand Name: EPLEX BLOOD CULTURE IDENTIFICATION GRAM NEGATIVE (BCID-GN) PANEL
• Common Device Name: GRAM-NEGATIVE BACTERIA AND ASSOCIATED RESISTANCE MARKERS
• Manufacturer (Section D): GENMARK DIAGNOSTICS, INC.; 5964 la place ct, suite 100; carlsbad CA 92008
• Manufacturer (Section G): GENMARK DIAGNOSTICS, INC.; 5964 la place ct, suite 100; na; carlsbad CA 92008
• Manufacturer Contact: alan maderazo ; 5964 la place ct, suite 100; na; carlsbad, CA 92008 ; 7604484308
• MDR Report Key: 15324287
• Report Number: 3008632402-2022-00067
• Device Sequence Number: 12138902
• Product Code: PEN
• UDI-Device Identifier: 00857167005313
• UDI-Public: 00857167005313
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K182619
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/30/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/04/2022
• Device Catalogue Number: 09556494001
• Device Lot Number: 91246383
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2022
• Initial Report FDA Received Date: 08/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALBUTEROL; BACTRIM; CHOLECALCIFEROL; FAMOTIDINE; GABAPENTIN; INSULIN; LATANOPROST; LEVOTHYROXINE; MAGNESIUM; MEOPROLOL TARTRATE; MEROPENEM; ROSUVASTATIN; ROSUVASTATIN; TACROMILUS; URSIDOIL
• Outcome Attributed to Adverse Event: Death
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 64 KG