MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-12-31 for VITROS ECI IMMUNODIAGNOSTIC SYSTEM ECI 3354 1072693 manufactured by Johnson & Johnson Clinical Diagnostic.
[15490594]
Signal reagent on the eci would not update volume even w/a new bottle loaded. The chem-tech reported test values as there were no codes or flags on the print out. A bent probe was found & replaced. All chemistries were rerun finding 2 significant reporting errors. One pregnancy test reported as 1. 35 miu/ml was actually 18. 7 miu/ml which is positive. The outpatient already had x-rays w/an ivp. A ckmb reported as negative was actually positive. The other pt was a code in er & was not revived.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 146796 |
| MDR Report Key | 146796 |
| Date Received | 1997-12-31 |
| Date of Report | 1997-12-17 |
| Date of Event | 1997-12-06 |
| Date Facility Aware | 1997-12-06 |
| Report Date | 1997-12-17 |
| Date Added to Maude | 1998-02-04 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VITROS ECI IMMUNODIAGNOSTIC SYSTEM |
| Generic Name | * |
| Product Code | LCI |
| Date Received | 1997-12-31 |
| Model Number | ECI 3354 |
| Catalog Number | 1072693 |
| Lot Number | 215 |
| ID Number | * |
| Device Availability | Y |
| Device Age | 2 MO |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 143067 |
| Manufacturer | JOHNSON & JOHNSON CLINICAL DIAGNOSTIC |
| Manufacturer Address | 100 INDIGO CREEK DR. ROCHESTER NY 14650 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-12-31 |