MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-05-09 for HEMOCHRON JR. MICROCOAGULATION ACT PLUS TEST JACT+ manufactured by Accriva Diagnostics.
[44781748]
This mdr submitted on 02/18/2016 references accriva diagnostics' complaint number (b)(4). Method: process evaluation performed. No testing methods performed. Results: no results available since no evaluation performed. Conclusion: device not returned. Accriva diagnostics has requested all data required for form 3500a.
Patient Sequence No: 1, Text Type: N, H10
[44781749]
Healthcare professional reported discrepant act results using a hemochron signature elite and act+ system during a cardiovascular procedure. The target act range was 300 to 325 seconds. After iv heparin was given, a whole blood sample was assayed side by side on two elite and act+ systems. One act result was 199 seconds, and the other act result was 398 seconds, the latter of which was considered higher than the expected result. A second sample tested on a third elite and act+ system was 318 seconds, which was within the target act range. The case was managed using the third elite and act+ system. No adverse effects were reported. Electronic and liquid quality controls consistently passed on all elite instruments. Storage of the reagent cuvettes and the procedure for whole blood collection by the user were reviewed and found to be consistent with labeled instructions.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002721930-2016-00003 |
| MDR Report Key | 5642810 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-05-09 |
| Date of Report | 2016-02-08 |
| Date of Event | 2016-02-04 |
| Date Mfgr Received | 2016-02-08 |
| Device Manufacturer Date | 2015-11-23 |
| Date Added to Maude | 2016-05-09 |
| 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 | JON MCDERMED |
| Manufacturer Street | 6260 SEQUENCE DRIVE |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8582632490 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEMOCHRON JR. MICROCOAGULATION ACT PLUS TEST |
| Generic Name | TEST, TIME, ACTIVATED WHOLE BLOOD CLOTTING TIME |
| Product Code | JBP |
| Date Received | 2016-05-09 |
| Model Number | JACT+ |
| Catalog Number | JACT+ |
| Lot Number | L5JAC915 |
| Device Expiration Date | 2017-02-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACCRIVA DIAGNOSTICS |
| Manufacturer Address | 6260 SEQUENCE DRIVE SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-09 |