MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1998-10-09 for VITROS ECI IMMUNODIAGNOSTIC SYSTEM 866893 manufactured by Ortho-clinical Diagnostics.
[19487741]
The analyzer produced a series of results with low light signal. No pt treatment was administered or withheld because of results produced. The cause is unk, but this scenario is consistent with prior incidents that were caused by depletion of signal reagent during operation of the analyzer, which could cause false negative creatinine myocardial bands and beta human chorionic gonadotropin.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319681-1998-00008 |
| MDR Report Key | 191647 |
| Report Source | 05 |
| Date Received | 1998-10-09 |
| Date of Report | 1998-09-11 |
| Date of Event | 1998-09-11 |
| Date Mfgr Received | 1998-09-11 |
| Device Manufacturer Date | 1998-05-01 |
| Date Added to Maude | 1998-10-16 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VITROS ECI IMMUNODIAGNOSTIC SYSTEM |
| Generic Name | IMMUNODIAGNOSTIC ANALYZER |
| Product Code | LCI |
| Date Received | 1998-10-09 |
| Model Number | NA |
| Catalog Number | 866893 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 186225 |
| Manufacturer | ORTHO-CLINICAL DIAGNOSTICS |
| Manufacturer Address | 100 INDIGO CREEK DR. ROCHESTER NY 146265101 US |
| Baseline Brand Name | VITROS ECI IMMUNODIAGNOSTIC SYSTEM |
| Baseline Generic Name | IMMUNODIAGNOSTIC ANALYZER |
| Baseline Model No | NA |
| Baseline Catalog No | 866893 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1998-10-09 |