MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1997-02-01 for CHIRON DIAGNOSTICS EXPRESS REACTION CUVETTES 751060 manufactured by Chiron Diagnostics Corp..
[41796]
A hole in the bottom of the reaction cuvettes allowed the reagent/pt sample to leak out of the bottom of the cuvette, causing negative results. The lab did not report out any pt results. Lab personnel called co field service personnel to investigate. There was no serious injury or death.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1519113-1997-00001 |
| MDR Report Key | 66930 |
| Report Source | 06 |
| Date Received | 1997-02-01 |
| Date of Report | 1997-01-31 |
| Date of Event | 1997-01-10 |
| Date Mfgr Received | 1997-01-13 |
| Device Manufacturer Date | 1996-11-01 |
| Date Added to Maude | 1997-02-07 |
| 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 | 3 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHIRON DIAGNOSTICS EXPRESS REACTION CUVETTES |
| Generic Name | EXPRESS MODEL 550/560 REACTION CUVETTES |
| Product Code | JRI |
| Date Received | 1997-02-01 |
| Returned To Mfg | 1997-01-14 |
| Model Number | NA |
| Catalog Number | 751060 |
| Lot Number | 1363 & 1369 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 66984 |
| Manufacturer | CHIRON DIAGNOSTICS CORP. |
| Manufacturer Address | 132 ARTINO ST. OBERLIN OH 44074 US |
| Baseline Brand Name | EXPRESS MODEL 550/550+ REACTION CUVETTES |
| Baseline Generic Name | REACTION CUVETTES |
| Baseline Model No | NA |
| Baseline Catalog No | 751060 |
| Baseline ID | * |
| Baseline Device Family | NA |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K872302 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-02-01 |