MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-30 for STA R MAX manufactured by Diagnostica Stago - Gennevilliers.
[125470359]
Quality check (qc) was run on the stago analyzer at 3:00am and was in range. At 11:00am, qc was done and was out of range. Troubleshooting was then started, hotline was called. It was determined that a leaking syringe and o-ring were causing the problem. The syringe and o-ring were replaced. Qc was repeated and still out of range. Hotline was called again, a different syringe and o-ring were replaced, qc was then repeated, and qc was in range. During the trouble shooting, the other stago analyzer was brought up with new reagents, and qc was run and in range. Patient testing was then started on that analyzer. The lab then started retesting of all previous samples from 3:00 am to 11:00am to determine if any erroneous results had been reported. Most partial thromboplastin time (ptt) results were outside of the allowable range of change (15%), as well as 2 d-dimer results, and 7 pt results. All corrected results were phoned to physicians or floors.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8018795 |
| MDR Report Key | 8018795 |
| Date Received | 2018-10-30 |
| Date of Report | 2018-09-26 |
| Date of Event | 2018-06-26 |
| Report Date | 2018-09-26 |
| Date Reported to FDA | 2018-09-26 |
| Date Reported to Mfgr | 2018-10-30 |
| Date Added to Maude | 2018-10-30 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STA R MAX |
| Generic Name | SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES |
| Product Code | JPA |
| Date Received | 2018-10-30 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | DIAGNOSTICA STAGO - GENNEVILLIERS |
| Manufacturer Address | 5 CENTURY DR PARSIPPANY NJ 07054 US 07054 |
| Brand Name | STA R MAX |
| Generic Name | SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES |
| Product Code | JPA |
| Date Received | 2018-10-30 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DIAGNOSTICA STAGO - GENNEVILLIERS |
| Manufacturer Address | 5 CENTURY DR PARSIPPANY NJ 07054 US 07054 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-30 |