MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-02-23 for BD MAX STAPHSR 442999 manufactured by Geneohm Sciences Canada Inc. (bd Diagnostics).
[5598478]
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.
Patient Sequence No: 1, Text Type: D, B5
[13060283]
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. "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007420875-2015-00001 |
| MDR Report Key | 4637455 |
| Report Source | 06 |
| Date Received | 2015-03-23 |
| Date of Report | 2015-02-23 |
| Date of Event | 2015-02-23 |
| Date Mfgr Received | 2015-02-23 |
| Device Manufacturer Date | 2014-12-01 |
| Date Added to Maude | 2015-03-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CHARLOTTE DANNENFELSER |
| Manufacturer Street | 2555 BOUL. DU PARCTECHNOLOGIQUE |
| Manufacturer City | QUEBEC GLP 4S5 |
| Manufacturer Country | CA |
| Manufacturer Postal | GLP 4S5 |
| Manufacturer Phone | 3164367 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BD MAX STAPHSR |
| Product Code | NQX |
| Date Received | 2015-02-23 |
| Catalog Number | 442999 |
| Lot Number | 4345870 |
| Device Expiration Date | 2015-10-20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GENEOHM SCIENCES CANADA INC. (BD DIAGNOSTICS) |
| Manufacturer Address | QUEBEC CA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2015-03-23 |