MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-21 for STA COMPACT MAX 58989 manufactured by Diagnostica Stago S.a.s.
[133712260]
(b)(6). The event occurred in france but the device is also marketed in the usa. The hotline (stago's phone technical support) was able to do a remote analysis of the instrument and did not find any system performance issues. No other patients were impacted. The patient was hospitalized but did not suffer any long-term effects. No additional information regarding the patient's condition is known at this time. System dump files are being reviewed and the investigation is continuing under file # (b)(4). Stago will provide a follow-up report(s) once relevant information has become available.
Patient Sequence No: 1, Text Type: N, H10
[133712261]
On (b)(6) 2018 9:29am: inconsistent results for pt=54. 1 sec and inr=12. 52 were produced for a single patient sample. On (b)(6) 2018 9:45am: the sample was re-tested and produced results of pt=42. 5 sec and inr=8. 19. On (b)(6) 2018 2:55pm: it was re-rested again and produced results of pt=24. 4sec and inr=3. 40. The released result was an average of the first two results. The inr was reported as 10. 36. The patient treatment was inappropriately modified. (vitamin k was administered). The corrected result was later released (inr=3. 40) at 2:55pm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8043273-2019-00001 |
| MDR Report Key | 8263851 |
| Date Received | 2019-01-21 |
| Date of Report | 2019-04-12 |
| Date of Event | 2018-11-03 |
| Date Facility Aware | 2019-01-10 |
| Report Date | 2019-01-21 |
| Date Reported to FDA | 2019-01-21 |
| Date Reported to Mfgr | 2019-01-18 |
| Date Mfgr Received | 2018-11-05 |
| Device Manufacturer Date | 2016-05-23 |
| Date Added to Maude | 2019-01-21 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. WALID BEN AMMAR |
| Manufacturer Street | 2 RUE PIERRE FOSSATI |
| Manufacturer City | FRANCONVILLE VAL-DOISE, 95130 |
| Manufacturer Country | FR |
| Manufacturer Postal | 95130 |
| Manufacturer G1 | DIAGNOSTICA STAGO S.A.S. |
| Manufacturer Street | 125 AVENUE LOUIS ROCHE PAE PARISPACE 3 |
| Manufacturer City | GENNEVILLIERS, 92230 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 92230 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | STA COMPACT MAX |
| Generic Name | IVD COAGULATION DEVICE/INSTRUMENT |
| Product Code | JPA |
| Date Received | 2019-01-21 |
| Catalog Number | 58989 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DIAGNOSTICA STAGO S.A.S |
| Manufacturer Address | DIAGNOSTICA STAGO S.A.S. 3 ALL?E THERESA ASNI?RES-SUR-SEINE, 92600 FR 92600 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-01-21 |