MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2004-09-09 for ELECSYS CLEAN CELL 11662970122 manufactured by Roche Diagnostics.
[339301]
A bottle defect prevented normal descent of the sipper probe producing instrument alarms and causing discrepant results for nine pt samples that were being tested for hcg, troponin t, ckmb or myoglobin. The operator noticed the bottle defect, exchanged the bottle and repeated the affected samples. The bottle manufacturer has implemented a video control system to prevent future occurrences.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2004-00884 |
| MDR Report Key | 546481 |
| Report Source | 04 |
| Date Received | 2004-09-09 |
| Date of Report | 2004-07-16 |
| Date of Event | 2004-06-25 |
| Date Mfgr Received | 2004-07-16 |
| Device Manufacturer Date | 2004-01-01 |
| Date Added to Maude | 2004-10-01 |
| 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 | DEBARA REESE |
| Manufacturer Street | 9115 HAGUE ROAD |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175213857 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ELECSYS CLEAN CELL |
| Generic Name | GENERAL PURPOSE REAGENT |
| Product Code | JCB |
| Date Received | 2004-09-09 |
| Model Number | NA |
| Catalog Number | 11662970122 |
| Lot Number | 14390100 |
| ID Number | NA |
| Device Expiration Date | 2006-01-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 535893 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE RD. INDIANAPOLIS IN 46250 US |
| Baseline Brand Name | ELECSYS CLEAN CELL |
| Baseline Generic Name | GENERAL PURPOSE REAGENT |
| Baseline Model No | NA |
| Baseline Catalog No | 11662970122 |
| Baseline ID | NA |
| Baseline Device Family | ELECSYS |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 24 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-09-09 |