MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-10-31 for ACL TOP 500 CTS 2800-40 00000280040 manufactured by Instrumentation Laboratory.
[125650474]
An investigation was conducted that included a review of the instrument clot curves. All aptt results illustrated well-formed curve formation, with appropriate clotting times detected and no concerning errors or warnings. The conclusion is that the values obtained on the acl top 500 cts were appropriately determined by the analyzer and the instrument 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
[125650475]
A customer reported that their acl top 500 cts generated an erroneous aptt result (36. 9 seconds) using hemosil synthasil. A patient was administered an increased dose of heparin based on this erroneous aptt result. Subsequently, another sample was drawn from the same patient (approximately 3 hours later) and it reported an aptt result of > 200. The heparin administration was stopped and the customer indicated that the patient's aptt result was brought back into the therapeutic range. There were no further reports of clinical implications for the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1217183-2018-00009 |
| MDR Report Key | 8024101 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-10-31 |
| Date of Report | 2018-10-31 |
| Date of Event | 2018-10-11 |
| Date Mfgr Received | 2018-10-12 |
| Date Added to Maude | 2018-10-31 |
| 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 ROAD |
| Manufacturer City | BEDFORD MA 01730 |
| Manufacturer Country | US |
| Manufacturer Postal | 01730 |
| Manufacturer Phone | 7818614597 |
| Manufacturer G1 | INSTRUMENTATION LABORATORY |
| Manufacturer Street | 180 HARTWELL ROAD |
| 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 500 CTS |
| Generic Name | ACL TOP, PRODUCT CODE: GKP |
| Product Code | GKP |
| Date Received | 2018-10-31 |
| Model Number | 2800-40 |
| Catalog Number | 00000280040 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INSTRUMENTATION LABORATORY |
| Manufacturer Address | 180 HARTWELL ROAD BEDFORD MA 01730 US 01730 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-10-31 |