MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2019-03-11 for STA COMPACT MAX PERCAGE 58989 manufactured by Diagnostica Stago S.a.s..
[138428074]
(b)(4). The event occurred in (b)(6) but the device is also marketed in the usa. The analyzer's logs have been retrieved. Investigations are still on going under corporate complaint (b)(4). Stago will provide a follow-up report(s) once relevant information has become available.
Patient Sequence No: 1, Text Type: N, H10
[138428075]
A patient sample yielded a result of 215ng/ml utilizing sta liatest ddi plus (prod# 00662 - lot# 254415) on an sta compact max analyzer on (b)(6) 2019. The laboratory was then informed that the patient had a thrombosis: the clinician contacted the laboratory by phone asking if the result was correct since the patient showed clear symptoms of dvt. This was confirmed by the radiology department. The same tube was retested the next day and yielded a result of >4000ng/ml.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8043273-2019-00002 |
| MDR Report Key | 8408876 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-03-11 |
| Date of Report | 2019-04-12 |
| Date of Event | 2019-02-12 |
| Date Facility Aware | 2019-03-06 |
| Report Date | 2019-03-11 |
| Date Reported to FDA | 2019-03-11 |
| Date Reported to Mfgr | 2019-03-11 |
| Date Mfgr Received | 2019-02-12 |
| Device Manufacturer Date | 2017-10-02 |
| Date Added to Maude | 2019-03-11 |
| 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 D'OISE, 95130 |
| Manufacturer Country | FR |
| Manufacturer Postal | 95130 |
| Manufacturer G1 | DIAGNOSTICA STAGO S.A.S. |
| Manufacturer Street | 3 ALLEE THERESA |
| Manufacturer City | ASNIERES-SUR-SEINE, 92600 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 92600 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STA COMPACT MAX PERCAGE |
| Generic Name | IVD COAGULATION DEVICE/INSTRUMENT |
| Product Code | JPA |
| Date Received | 2019-03-11 |
| Catalog Number | 58989 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DIAGNOSTICA STAGO S.A.S. |
| Manufacturer Address | 3 ALL?E THERESA ASNI?RES-SUR-SEINE, 92600 FR 92600 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-03-11 |