MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-03-01 for ACL TOP 550 CTS 2800-45 00000280045 manufactured by Instrumentation Laboratory.
[137660980]
An investigation was conducted that included review of the instrument aptt clot curves along with the verification of sample and reagent fluidic precision. Aptt quality control was within passing criteria prior to patient testing and immediately after the questionable results were generated. The conclusion is that the acl top 550 cts was performing as intended. Based on the above, there was no indication of an instrument malfunction and no remedial action is needed.
Patient Sequence No: 1, Text Type: N, H10
[137660981]
A customer reported that their acl top 550 cts generated erroneous aptt results using hemosil synthasil. Three patients were administered an increased dose of heparin based on the erroneous aptt results. The aptt results were later corrected and the heparin doses were adjusted as appropriate. After the additional dose of heparin, the patients were monitored and there were no complications from the additional heparin administered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1217183-2019-00003 |
| MDR Report Key | 8383931 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-03-01 |
| Date of Report | 2019-03-01 |
| Date of Event | 2019-02-09 |
| Date Mfgr Received | 2019-02-09 |
| Device Manufacturer Date | 2018-06-09 |
| Date Added to Maude | 2019-03-01 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. REBA DAOUST |
| Manufacturer Street | 180 HARTWELL RD |
| Manufacturer City | BEDFORD MA 01730 |
| Manufacturer Country | US |
| Manufacturer Postal | 01730 |
| Manufacturer G1 | INSTRUMENTATION LABORATORY |
| Manufacturer Street | 180 HARTWELL RD |
| Manufacturer City | BEDFORD MA 01730 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01730 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACL TOP 550 CTS |
| Generic Name | INSTRUMENT, COAGULATION, AUTOMATED |
| Product Code | GKP |
| Date Received | 2019-03-01 |
| Model Number | 2800-45 |
| Catalog Number | 00000280045 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INSTRUMENTATION LABORATORY |
| Manufacturer Address | 180 HARTWELL RD BEDFORD MA 01730 US 01730 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-03-01 |