MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-05-26 for XPERT MTB/RIF GXMTB/RIF GXMTB/RIF-10 manufactured by Cepheid.
[109359622]
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.
Patient Sequence No: 1, Text Type: N, H10
[109359623]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004530258-2018-00002 |
| MDR Report Key | 7547062 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-05-26 |
| Date of Report | 2018-05-25 |
| Date of Event | 2017-04-27 |
| Date Mfgr Received | 2018-04-27 |
| Date Added to Maude | 2018-05-26 |
| 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 | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JAMIE TOBIN |
| Manufacturer Street | 904 CARIBBEAN DR |
| Manufacturer City | SUNNYVALE CA 94089 |
| Manufacturer Country | US |
| Manufacturer Postal | 94089 |
| Manufacturer Phone | 4089629695 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | XPERT MTB/RIF |
| Generic Name | GXMTB |
| Product Code | NQX |
| Date Received | 2018-05-26 |
| Model Number | GXMTB/RIF |
| Catalog Number | GXMTB/RIF-10 |
| Lot Number | 1000062041 |
| 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 DR SUNNYVALE CA 94089 US 94089 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2018-05-26 |