MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-06-25 for HEMOCHRON SIGNATURE ELITE MICROCOAGULATION SYSTEM manufactured by Accriva Diagnostics.
[112754521]
This mdr references accriva diagnostics' complaint number (b)(4) for the hemochron signature elite, serial number (b)(4), the parent case. This mdr also captures 2 child complaints - (1) (b)(4) captures the second hemochron signature elite microcoagulation system used during the cardiovascular procedure (se3972), and (2) (b)(4) captures the hemochron jr act-lr (low-range) reagent cuvette used. (b)(4). No testing methods performed. Process evaluation by dhr review showed no ncs or capas. The instrument was returned for repair 3 times: sbios failure ((b)(6) 2012), display blank ((b)(6) 2013) and program not run ((b)(6) 2015). None of the failures that were repaired are related to the current complaint. Results code: no results available since no evaluation performed. Conclusion code: device not returned. Accriva diagnostics has requested all data required for form 3500a. This is the initial 30-day report that precedes the instrument evaluation. Mdr follow-up #1 will be submitted once the results of the evaluation of se3858 is completed.
Patient Sequence No: 1, Text Type: N, H10
[112754522]
Healthcare professional reported that a hemochron signature elite and low-range act system reported inconsistent act results during a cardiovascular procedure. The patient was receiving intermittent doses of intravenous heparin with a target act range of 300 to 350 seconds. One blood sample generated an act result that was 236 seconds, which was a lower than expected result. The same blood sample was run on a second hemochron signature elite system, which generated an act result of 368 seconds. This act result of 368 seconds was used for patient management. The hemochron signature elite and low-range act system passed electronic and liquid qc before the procedure. No bleeding, thrombosis or other medical complications were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2250033-2018-00013 |
| MDR Report Key | 7634639 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-06-25 |
| Date of Report | 2018-08-09 |
| Date of Event | 2018-05-07 |
| Date Mfgr Received | 2018-07-09 |
| Device Manufacturer Date | 2009-02-20 |
| Date Added to Maude | 2018-06-25 |
| 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 |
| Manufacturer G1 | ACCRIVA DIAGNOSTICS |
| Manufacturer Street | 6260 SEQUENCE DRIVE |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92121 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEMOCHRON SIGNATURE ELITE MICROCOAGULATION SYSTEM |
| Generic Name | SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES |
| Product Code | JPA |
| Date Received | 2018-06-25 |
| Returned To Mfg | 2018-07-19 |
| Model Number | ELITE |
| Catalog Number | ELITE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-06-25 |