MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-02-11 for ACL ELITE manufactured by Instrumentation Laboratory Co.
[16862592]
Changes in laboratory values. Equipment taken out of service and manufacturer contacted for the troubleshooting. Service completed on (b)(6) 2015. The sample block assembly was replaced and equipment returned to service at that time. No apparent long-term adverse effect for the patients.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5040773 |
| MDR Report Key | 4528273 |
| Date Received | 2015-02-11 |
| Date of Report | 2015-02-11 |
| Date Added to Maude | 2015-02-20 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACL ELITE |
| Generic Name | COAGULATION INSTRUMENT |
| Product Code | JKP |
| Date Received | 2015-02-11 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INSTRUMENTATION LABORATORY CO |
| Manufacturer Address | BREA 92821 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-02-11 |