MAUDE Adverse Event Report: CEPHEID XPERT MTB/RIF; GXMTB

Model Number GXMTB/RIF

Device Problem No Apparent Adverse Event (3189)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 04/27/2017

Event Type  Injury  

Manufacturer Narrative

There is no indication or allegation from the field/clinic that the device contributed to the incident.Cepheid investigation has determined that this is not a device malfunction, product is adequately labeled and the product has performed according to product claims.Cepheid has requested for additional information with regards to this case (multiple attempts made) and has not received any more information.

Event Description

The clinician (in (b)(6) were this incident occurred) received a (b)(6) test with the xpert mtb/rif that was later confirmed as incorrect via an alternate methodology.The result of the xpert mtb/rif was (b)(6) detected very low and (b)(6) detected.The patient was subsequently treated for the condition with second line antibiotics (treatment regimen unknown) which might have resulted in kidney failure.The customer in (b)(6) has not responded to multiple attempts for request of additional information and it is not believed that the medical equipment malfunctioned.A review of complaint data does not show that there is any trend for this issue.This event happened in (b)(6) (ce mark product) and it is not believed that such a situation is likely to occur in the united states (substantially equivalent product sold in the united states).The packages insert labeling clearly states that rif resistance needs to be confirmed by a reference laboratory and the standard of care will prevent occurrence of such incidents (toxicity monitoring etc.) the package insert limitation state: due to the low prevalence of rifampin resistant tb in the united states and the implications of rifampin resistance for treatment, all mtb-complex strains determined to be rifampin resistant by the xpert mtb/rif assay must have the presence of rifampin resistance associated mutations of the rpob gene confirmed by a reference laboratory.Additional testing for the presence of mutations associated with resistance to other drugs for the treatment of tb should also be performed.

• Brand Name: XPERT MTB/RIF
• Type of Device: GXMTB
• Manufacturer (Section D): CEPHEID; 904 caribbean dr; sunnyvale CA 94089
• Manufacturer Contact: jamie tobin ; 904 caribbean dr; sunnyvale, CA 94089 ; 4089629695
• MDR Report Key: 7547062
• MDR Text Key: 109359622
• Report Number: 3004530258-2018-00002
• Device Sequence Number: 1
• Product Code: NQX
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K143302
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 05/25/2018

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 Model Number: GXMTB/RIF
• Device Catalogue Number: GXMTB/RIF-10
• Device Lot Number: 1000062041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/27/2018
• Initial Date FDA Received: 05/26/2018
• 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?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening