MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-03-27 for STA-R EVOLUTION 58978 manufactured by Diagnostica Stago S.a.s..
[144990582]
(b)(4). On 20mar2019: the manufacturer gave their conclusion to the investigation. The diagnostica stago field support engineer noticed that needle #1 was bent and hitting the edge of the tube/vial, disrupting sampling. Due to contamination the parts replaced (needle #1 and washing well #3) were discarded but pictures were provided. Qc was in before and after the sample run. There was no specific warning to the customer and results were released. The most likely root cause was a combination of failed needle #1 and washing well #3. Since the parts were discarded due to contamination, it is not possible to investigate any further. The manufacturer has concluded their investigation into this matter.
Patient Sequence No: 1, Text Type: N, H10
[144990583]
On (b)(6) 2019: the diagnostica stago inc. Hotline received a call from the medical college of (b)(6) coag lab stating that erroneous results were produced and released. The results were questioned by the nursing staff and rerun on their other instrument. It produced results matching the previous ones. On (b)(6) 2019: the customer reported that the erroneous results failed delta checks but were released. The affected tests were for pt, ptt, d-dimer, and fibrinogen. The customer also stated that the tests were not rerun as previously stated and were accepted knowing that the delta checks had failed. On (b)(6) 2019: the customer provided information on the stago questionnaire. A total of five patient results were affected and there was no harm or injury to any of the patients. The manufacturer was notified by email about a potential reportable event. This incident is considered a malfunction since qc was in range before and after the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8043273-2019-00004 |
| MDR Report Key | 8455816 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-03-27 |
| Date of Report | 2019-02-28 |
| Date of Event | 2019-02-28 |
| Date Facility Aware | 2019-02-28 |
| Report Date | 2019-03-19 |
| Date Reported to Mfgr | 2019-03-19 |
| Date Mfgr Received | 2019-03-05 |
| Device Manufacturer Date | 2013-04-15 |
| Date Added to Maude | 2019-03-27 |
| 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 ALL |
| Manufacturer City | ASNI 92600 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 92600 |
| Single Use | 3 |
| Remedial Action | RP |
| 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 | 2019-03-27 |
| 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 | 2019-03-27 |