MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-07-31 for STA COMPACT MAX IVD COAGULATION DEVICE/INSTRUMENT 58990 manufactured by Diagnostica Stago S.a.s..
[115596424]
(b)(4). A stago field support engineer was dispatched to investigate the issue. While at the customer site he "cleaned the cuvette suction tip and head. Checked safety features in multiple situations, every situation tested worked as specified. Couldn't duplicate the issue reported. " system testing: passed endurance and qc. (b)(6) signed the work order containing the work performed by the fse stated above. Investigations are currently in progress. The conclusion will be communicated as soon as it is available.
Patient Sequence No: 1, Text Type: N, H10
[115596425]
On (b)(6) 2018, (b)(6) contacted the stago hotline to report "that one of his techs,... Was hurt while working on the stago instrument. She was trying to retrieve a broken cuvette out of the instrument. (b)(6) says that his tech stated that the sample arm moved suddenly and bruised and scratched her arm. She was placed on antibiotics. An incident report was requested by stago but was not supplied by the customer. A stago field support engineer was dispatched to investigate the issue. While at the customer site he "cleaned the cuvette suction tip and head. Checked safety features in multiple situations, every situation tested worked as specified. Couldn't duplicate the issue reported. " system testing: passed endurance and qc. (b)(6) signed the work order containing the work performed by the fse stated above.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8043723-2018-00001 |
| MDR Report Key | 7735696 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-07-31 |
| Date of Report | 2018-06-19 |
| Date of Event | 2018-06-19 |
| Date Facility Aware | 2018-06-19 |
| Report Date | 2018-07-17 |
| Date Reported to FDA | 2018-07-17 |
| Date Reported to Mfgr | 2018-07-17 |
| Date Mfgr Received | 2018-06-22 |
| Device Manufacturer Date | 2015-07-09 |
| Date Added to Maude | 2018-07-31 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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, FR |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 92230, FR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STA COMPACT MAX |
| Generic Name | COMPACT MAX |
| Product Code | JPA |
| Date Received | 2018-07-31 |
| Model Number | IVD COAGULATION DEVICE/INSTRUMENT |
| Catalog Number | 58990 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 3 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DIAGNOSTICA STAGO S.A.S. |
| Manufacturer Address | 125 AVENUE LOUIS ROCHE PAE PARISPACE 3 GENNEVILLIERS, 92230 FR 92230 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-07-31 |