MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-03-20 for STA-R EVOLUTION 58978 manufactured by Diagnostica Stago S.a.s..
[139365378]
(b)(4). 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
[139365379]
On (b)(6) 2019: the diagnostica stago inc. Hotline received a call from the medical college of virginia coag lab stating they had an earlier issue with a leaking needle #1 that was discovered during a cuvette jam. During this time, erroneous results were produced and released. The account reported that all results were corrected and the physicians notified, but two patients were treated based on the results. One was transfused blood products (1 unit of cryoprecipitate) and another had a procedure delayed. The procedure was determined to be a transesophageal echocardiogram (tee). On (b)(6) 2019: a diagnostica stago inc. Field support engineer (fse) arrived at the customer facility. The customer had already addressed the issue of the leaking needle by tightening the fitting. The fse noted that the qc was in without any apparent shifts. The customer did mention to the fse that there were some correlation issues for ptt between their two instruments. The fse discovered some carryover on the instrument in question. All needles and syringes were replaced. Another carryover and precision test was performed and the instrument was working within stago specifications. On (b)(6) 2019: additional information was received from the customer regarding the patients' conditions. It was well documented by the director of hemostasis that the results for both patients "were not life threatening, they did not result in serious injury, bodily impairment, permanent damage, or death". The one patient was "inconvenienced with having the procedure performed the following day". The other was "inconvenienced with having to receive a blood product".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8043273-2019-00003 |
| MDR Report Key | 8435968 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-03-20 |
| Date of Report | 2019-02-20 |
| Date of Event | 2019-02-20 |
| Date Facility Aware | 2019-02-20 |
| Report Date | 2019-03-20 |
| Date Reported to FDA | 2019-03-20 |
| Date Reported to Mfgr | 2019-03-15 |
| Date Mfgr Received | 2019-02-28 |
| Date Added to Maude | 2019-03-20 |
| 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 | 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 ALL |
| Manufacturer City | ASNI 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-R EVOLUTION |
| Generic Name | IVD COAGULATION DEVICE/INSTRUMENT |
| Product Code | JPA |
| Date Received | 2019-03-20 |
| Model Number | 58978 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 6 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 | 2019-03-20 |