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

Model Number	XPERT MRSA/SA BC
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Sepsis (2067)
Date of Event	02/21/2018
Type of Reportable Event	Death
Additional 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 or Problem 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
• Common Device Name: GXMRSA/SA-BC-10
• Manufacturer (Section D): CEPHEID; 904 caribbean drive; sunnyvale CA 94089
• MDR Report Key: 7380500
• Report Number: 3004530258-2018-00001
• Device Sequence Number: 16424375
• Product Code: NQX
• UDI-Device Identifier: 07332940000141
• UDI-Public: 07332940000141
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K101879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 03/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: 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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2018
• Initial Report FDA Received Date: 03/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 75 YR