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

Device Problem False Positive Result (1227)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/24/2022

Event Type  Death  

Manufacturer Narrative

Analysis : internal review of qc release data for affected bcid-gn lot 91292811 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 (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 bcid-gn panel lot.Genmark was not advised of any patient harm or adverse event.

Event Description

On (b)(6) 2022, genmark was advised of discrepant results associated with the eplex bcid-gn panel tested on (b)(6) 2022.The eplex result for the sample in question reported detection of citrobacter, enterobacter cloacae complex, klebsiella pneumoniae group, where the citrobacter result was considered unexpected positive.Culture for the same sample resulted in identification of enterobacter cloacae complex, klebseiella pneumoniae and streptococcus mitis.Although not reported as an unexpected result by the customer, genmark is investigating an unexpected negative result for the eplex bcid-gn pan-gram positive result since streptococcus mitis is included in this result.On (b)(6) 2022, genmark was advised the patient associated with these results is deceased.Genmark was advised the eplex bcid-gn results including the unexpected positive citrobacter result were reported to the physician, although when available the culture results were deemed to be correct.Genmark made multiple attempts to acquire additional information about the patient and the event including association of the eplex result to the patient outcome, however on (b)(6) 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 signals were generated for the eplex bcid-gn run suggesting the consumable performed as expected and no malfunction was observed.The sample was provided by the customer and the investigation is ongoing.

Manufacturer Narrative

During the investigation, it was observed that genmark was notified of the event on september 13, 2022 however, the initial mdr reported the date event on september 14, 2022.Section g3 of this report captures the true reported date.Additionally, the patients age and gender were reported and therefore were added to section a2 and a3.

Event Description

As part of the investigation, the sample in question was provided to genmark where it was tested internally on the eplex bcid-gn panel.The sample was also sent to an external vendor for sequencing.The results of the additional investigation were presented on october 21, 2022, where testing confirmed the original eplex bcid-gn panel results: the citrobacter call on the eplex bcid-gn panel was positive upon in house re-test of the sample.Additionally, external sequencing of the sample identified citrobacter.These outcomes confirm the original eplex bcid-gn panel results (positive for citrobacter) and support the conclusion that the eplex bcid-gn panel performed as expected.The pan gram-positive call on the eplex bcid-gn panel was negative upon internal re-test of the sample.Additionally, external sequencing of the sample did not identify streptococcus mitis.In other words, the results did not identify any target included within the pan-gp assay on the eplex bcid-gn panel.These outcomes confirm the original eplex bcid-gn panel results (negative for gram positive organism) and support the conclusion that the eplex bcid-gn panel performed as expected.

• Brand Name: EPLEX BLOOD CULTURE IDENTIFICATION GRAM NEGATIVE (BCID-GN) PANEL
• Type of Device: 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: 15591562
• MDR Text Key: 301623351
• Report Number: 3008632402-2022-00070
• Device Sequence Number: 1
• Product Code: PEN
• UDI-Device Identifier: 00857167005313
• UDI-Public: 00857167005313
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182619
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/27/2022

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/12/2023
• Device Catalogue Number: 09556494001
• Device Lot Number: 91292811
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/14/2022
• Initial Date FDA Received: 10/12/2022
• Supplement Dates Manufacturer Received: 09/13/2022
• Supplement Dates FDA Received: 10/27/2022
• 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: 77 YR
• Patient Sex: Female