MAUDE Adverse Event Report: GENEOHM SCIENCES CANADA INC. (BD DIAGNOSTICS) BD MAX STAPHSR

Catalog Number 442999

Device Problem False Negative Result (1225)

Patient Problems Death (1802); Staphylococcus Aureus (2058)

Event Date 02/21/2015

Event Type  Death  

Event Description

On (b)(6) 2015, (b)(6) reported obtaining a (b)(6) result using the md max staphsr assay.A (b)(6) male patient was admitted to the hospital through its emergency room on (b)(6) 2015 after testing performed its emergency room on (b)(6) 2015 after testing performed at a clinic showed he had abnormally low hemoglobin levels.On (b)(6) 2015, the patient's blood was tested on the bd bactec fx instrumented blood culture system.The patient received one dose of vancomycin on the morning of (b)(6) 2015.On the same day, bd bactec reported a positive blood culture result (one bottle of ten sets of culture bottles of the patient's blood came back positive).The hospital then used its in-house validated lab procedure to test the blood culture sample from the positive bottle using the bd max staphsr polymerase chain reaction (pcr) assay, which per the product package insert (pi) is intended for use with a nasal swab, not a blood culture sample.The bd max staphsr reported as positive for staphylococcus aureus ("sa") and (b)(6) for (b)(6).The patient's treatment was changed from vancomycin to nafcillin.On (b)(6) 2015, the lab tested the blood culture for sensitivity using biomerieux vitek 2, which indicated the presence of (b)(6).The lab noted the discrepancy between the bd max staphsr result and the vitek 2 result but did not report the result to the treating physician at this time, seeking to check the purity plate the next day.On (b)(6) 2015, the laboratory repeated the bd max staphsr molecular test and the biomerieux vitek 2 test and received the same results.On (b)(6) 2015, the lab entered the vitek 2 result into the hospital's computer system and notified the physician of the vitek 2 result indicating the presences of (b)(6).The patient received another dose of vancomycin on (b)(6) 2015 before being placed on palliative care.The patient passed away on (b)(6) 2015 and no autopsy was performed.

Manufacturer Narrative

At bd's request, (b)(6) provided the bd max staphsr run data and 2 samples from the patient (positive blood culture and an isolate).Bd's analysis of the data and returned samples showed that the assay performed correctly and the patient's (b)(6) result was due to infection with a (b)(6) variant (mrej genotype xi) not targeted by the assay.Per the pi, "the bd max staphsr assay performed on the md max system is an automated qualitative in vitro diagnostic test for the direct detection and differentiation of sa and (b)(6) dna from nasal swabs in patients at risk for nasal colonization.The test utilizes real-time pcr for the amplification of (b)(6)/sa dna and fluorogenic target-specific hybridization probes for the detection of the amplified dna.The bd max staph sr assay is intended to aid in the prevention and control of (b)(6) and sa infections in healthcare settings.It is not intended to diagnose (b)(6) or sa infections nor guide or monitor treatment for (b)(6)/sa infections.A negative result does not preclude nasal colonization.Concomitant cultures are necessary to recovery organisms for epidemiological typing or for further susceptibility testing" the pi also notes, "the bd max staphsr assay is designed to detect mrej genotypes i, ii, iii, iv, v, vi, vii, ix, xiii, xiv and xxi which represents most of meca and mecc harboring (b)(6) strains (belonging to different sccmec/mrej types) accounting for more than (b)(4) of worldwide strains tested by bd to date.The ability of the bd max staphsr to detect other mrej genotypes is unknown.".

• Brand Name: BD MAX STAPHSR
• Manufacturer (Section D): GENEOHM SCIENCES CANADA INC. (BD DIAGNOSTICS); quebec ; CA
• Manufacturer Contact: charlotte dannenfelser ; 2555 boul. du parctechnologique; quebec GLP 4-S5 ; CA GLP 4S5 ; 3164367
• MDR Report Key: 4637455
• MDR Text Key: 5598478
• Report Number: 3007420875-2015-00001
• Device Sequence Number: 1
• Product Code: NQX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132822
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/23/2015

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: 10/20/2015
• Device Catalogue Number: 442999
• Device Lot Number: 4345870
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/23/2015
• Initial Date FDA Received: 02/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2014
• 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): Death
• Patient Age: 62 YR