MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2018-10-22 for HEMOCHRON SIGNATURE ELITE INTERNATIONAL ELITE-INT manufactured by Accriva Diagnostics.
[126246717]
This mdr references accriva diagnostics' complaint number (b)(4) for the hemochron signature elite international instrument, serial number (b)(4). Accriva diagnostics' complaint number (b)(4) referenced the child case capturing the disposable hemochron jr. Act-lr device (lot number j7jlr194) that was used during the procedure. Method: testing of actual/suspected device. Dhr review showed no ncs, capa, or a relevant history of repair. Results: no device problem found. The instrument was tested to heparin sensitivty procedure qc-188 using 2 lots of act-lr cuvettes and side by side with 3 other control instruments. The device performed within specifications. Conclusion: no problem detected. This mdr serves as the initial and final report for the hemochron signature elite and act-lr microcoagulation system, instrument serial number (b)(4), lot j7jlr194. The complaint was not confirmed.
Patient Sequence No: 1, Text Type: N, H10
[126246718]
Healthcare professional working in a hospital in (b)(6) reported that two hemochron signature elite and act low-range assay systems reported inconsistent act results when the meters were run side-to-side during a pci and stent placement procedure. The patient was receiving intermittent doses of intravenous heparin with a target act range of 300-350 seconds. The same lot number of hemochron jr act-lr cuvettes (j7jlr194) was used on both meters throughout the procedure. One blood sample generated a pair of act results that differed significantly from one another. The act result assayed on the elite named in this complaint ((b)(4)) was 254 seconds, which was lower than the target act. The act result reported on the second elite ((b)(4)) was 321 seconds, which was an expected result. The act result of 321 seconds was used for patient management. No bleeding, thrombosis or other medical complications were reported. Both hemochron signature elite instruments passed electronic qc before the procedure. Act-lr readings with liquid qc (normal and abnormal levels) were within their acceptable ranges when run on both instruments. The distributor asked the customer to return the device for evaluation, however, the customer declined to do so as of (b)(6) 2018, when accriva closed the initial complaint. The complaint case was reopened on (b)(6) 2018 when the customer decided to return the instrument to accriva for evaluation because of recurrent instances of reporting inconsistent act results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2250033-2018-00024 |
| MDR Report Key | 7993153 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2018-10-22 |
| Date of Report | 2018-09-26 |
| Date of Event | 2018-03-09 |
| Date Mfgr Received | 2018-09-26 |
| Device Manufacturer Date | 2015-03-20 |
| Date Added to Maude | 2018-10-22 |
| 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 | BIOMEDICAL ENGINEER |
| 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 INTERNATIONAL |
| Generic Name | SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES |
| Product Code | JPA |
| Date Received | 2018-10-22 |
| Returned To Mfg | 2018-10-05 |
| Model Number | ELITE-INT |
| Catalog Number | ELITE-INT |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2018-10-22 |