MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2010-05-04 for XPERT MRSA/SA BC GXMRSA/SA-BC-10 manufactured by Cepheid.
[1494861]
On april 1, a (b) (6) male was admitted to hospital complaining of back pain; pt had a history of renal insufficiency and congestive heart failure. On april 6, pt becomes febrile, blood was drawn for blood culture and test was positive by cepheid gx (b) (6)/sa bc assay for (b) (6). On april 7, pt was treated with invanz (ertapenem) antibiotic; pt fell in room, hit head, cardiac arrest, was revived and sent to icu; nasal swab taken for (b) (6) culture test; pt given 1500 mg vancomycin. On april 8, pt was given oxacillin. On april 9, blood culture agar plate was positive for (b) (6) and april 6, culture sample repeated on cepheid gx (b) (6)/sa bc test was now (b) (6) positive; hospital lab contacted cepheid to report the discrepancy in test results (b) (4). On april 11, the pt expired. On april 28, a meeting was held between hospital lab personnel and cepheid personnel to review the details of the complaint during which cepheid learned for first time pt had died. Cepheid began mdr process following internal procedure as specified in (b) (4) (medical device reporting sop. On april 29 and april 30 follow up meetings were held with lab pathologist dr (b) (6) to confirm details of complaint.
Patient Sequence No: 1, Text Type: D, B5
[8645154]
Intended use of device: the cepheid xpert (b) (6) blood culture assay performed on the genexpert dx system is a qualitative in vitro diagnostic test intended for the detection of (b) (6) and (b) (6) dna directly from pt positive blood cultures. The assay utilizes automated real-time polymerase chain reaction (pcr) for the amplification of (b) (6) specific dna targets and fluorogenic target-specific hybridization probes for the real-time detection of the amplified dna. The assay is performed directly on positive blood culture specimens using bd bactec plus aerobic/f blood culture bottles that are determined as gram positive (b) (6) in clusters (b) (6) or as gram positive (b) (6) in singles (b) (6) by gram stain. The cepheid xpert (b) (6) blood culture assay is not intended to monitor treatment for (b) (6) infections. Subculturing of positive blood cultures is necessary to recover organisms for susceptibility testing or for epidemiological typing. Cepheid contact for mdr: (b) (4), vice president, regulatory compliance & quality systems, cepheid. (b) (4). (b) (4)
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004530258-2010-00001 |
| MDR Report Key | 1675196 |
| Report Source | 05,06,07 |
| Date Received | 2010-05-04 |
| Date of Report | 2010-05-03 |
| Date of Event | 2010-04-11 |
| Date Mfgr Received | 2010-04-09 |
| Device Manufacturer Date | 2010-01-29 |
| Date Added to Maude | 2010-05-06 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 904 CARIBBEAN DRIVE |
| Manufacturer City | SUNNYVALE CA 94089 |
| Manufacturer Country | US |
| Manufacturer Postal | 94089 |
| Manufacturer Phone | 4085414191 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | XPERT MRSA/SA BC |
| Generic Name | NONE |
| Product Code | NQX |
| Date Received | 2010-05-04 |
| Catalog Number | GXMRSA/SA-BC-10 |
| Lot Number | 1302 |
| Device Expiration Date | 2011-05-29 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2010-05-04 |