MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-12-28 for OCCULT BLOOD TEST KIT manufactured by Laboratory Diagnostics Co, Inc..
[21636108]
After testing, it was found that the expected results could not be successfully reproduced. The positive and negative controls were checked for the appropriate color reaction and the mfr's specified color change was not achieved. It is impossible to confirm the pt results if the controls can not be verified. This product does not meet the requirements of the agency that this facility must abide by.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4000984 |
| MDR Report Key | 29088 |
| Date Received | 1995-12-28 |
| Date of Report | 1995-09-20 |
| Date Added to Maude | 1995-12-29 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OCCULT BLOOD TEST KIT |
| Generic Name | OCCULT BLOOD TEST KIT |
| Product Code | JIP |
| Date Received | 1995-12-28 |
| Lot Number | 77583 |
| Operator | OTHER |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 30101 |
| Manufacturer | LABORATORY DIAGNOSTICS CO, INC. |
| Manufacturer Address | 620 RT 520 MORGANVILLE NJ 07751 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1995-12-28 |