MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-03-28 for XPERT MRSA/SA BC GXMRSA/SA-BC-10 manufactured by Cepheid.
[103771706]
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).
Patient Sequence No: 1, Text Type: N, H10
[103771707]
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).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004530258-2018-00001 |
| MDR Report Key | 7380500 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-03-28 |
| Date of Report | 2018-03-28 |
| Date of Event | 2018-02-21 |
| Date Mfgr Received | 2018-02-26 |
| Device Manufacturer Date | 2017-12-26 |
| Date Added to Maude | 2018-03-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. ERIC KANAZAWA |
| Manufacturer Street | 904 CARIBBEAN DRIVE |
| Manufacturer City | SUNNYVALE CA 94089 |
| Manufacturer Country | US |
| Manufacturer Postal | 94089 |
| Manufacturer Phone | 4085428554 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | XPERT MRSA/SA BC |
| Generic Name | GXMRSA/SA-BC-10 |
| Product Code | NQX |
| Date Received | 2018-03-28 |
| Model Number | XPERT MRSA/SA BC |
| Catalog Number | GXMRSA/SA-BC-10 |
| Lot Number | 1000078626 |
| Device Expiration Date | 2019-02-17 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CEPHEID |
| Manufacturer Address | 904 CARIBBEAN DRIVE SUNNYVALE CA 94089 US 94089 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2018-03-28 |