MAUDE Adverse Event Report: CEPHEID XPERT MRSA/SA BC; GXMRSA/SA-BC-10

Model Number XPERT MRSA/SA BC

Device Problem No Apparent Adverse Event (3189)

Patient Problem Sepsis (2067)

Event Date 02/21/2018

Event Type  Death  

Manufacturer Narrative

There is no indication or allegation from the field/clinic that the device contributed to the incident.(b)(6) investigation has determined that this is not a device malfunction, product is adequately labeled and the product has performed according to product claims.(b)(4).

Event Description

This case concerned a discrepancy between (b)(6) results, which were initially reported (b)(6) / (b)(6) on (b)(6) 2018.The following day ((b)(6) 2018), (b)(6) grew in culture and was confirmed as (b)(6) by microscan and disk diffusion.The blood culture bottle was retested and was determined to be (b)(6) by (b)(6) (likely a mutation within (b)(6) targets probe or binding sites).According to the lab, there was a delay in reporting (b)(6) by approximately 24 hours and during this time the patient was not on (b)(6) active drugs.Patient was a (b)(6) year old male from a nursing home admitted for sepsis.Patient died on (b)(6) 2018, although his antibiotic therapy had been changed to three drugs to which the (b)(6) organism was susceptible.The discrepant result may have contributed to the patient's death.A follow-up blood culture using (b)(6) reported (b)(6) (b)(6).

• Brand Name: XPERT MRSA/SA BC
• Type of Device: GXMRSA/SA-BC-10
• Manufacturer (Section D): CEPHEID; 904 caribbean drive; sunnyvale CA 94089
• Manufacturer Contact: eric kanazawa ; 904 caribbean drive; sunnyvale, CA 94089 ; 4085428554
• MDR Report Key: 7380500
• MDR Text Key: 103771706
• Report Number: 3004530258-2018-00001
• Device Sequence Number: 1
• Product Code: NQX
• UDI-Device Identifier: 07332940000141
• UDI-Public: 07332940000141
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101879
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/17/2019
• Device Model Number: XPERT MRSA/SA BC
• Device Catalogue Number: GXMRSA/SA-BC-10
• Device Lot Number: 1000078626
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/26/2018
• Initial Date FDA Received: 03/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/26/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 75 YR