MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2001-08-02 for C-REACTIVE PROTEIN (LATEX) 0764930 manufactured by Roche Diagnostics.
[209235]
Notified by global affiliate that reagent cassettes may contain under-filled or nearly empty reagent bottles. Analyzer does not contain level detection system therefore no alarm would warn customers. Patient samples and controls may produce falsely low or high results without an alarm or there could be unacceptable precision when patient or control material is reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2001-00166 |
| MDR Report Key | 347104 |
| Report Source | 00 |
| Date Received | 2001-08-02 |
| Date of Report | 2001-08-02 |
| Date of Event | 2001-08-01 |
| Date Mfgr Received | 2001-08-01 |
| Device Manufacturer Date | 2000-01-01 |
| Date Added to Maude | 2001-08-16 |
| 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 | 3 |
| Manufacturer Contact | DEBARA REEK |
| Manufacturer Street | 9115 HAGUE RD |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175763857 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | C-REACTIVE PROTEIN (LATEX) |
| Generic Name | REAGENT CASSETTE |
| Product Code | DCK |
| Date Received | 2001-08-02 |
| Model Number | NA |
| Catalog Number | 0764930 |
| Lot Number | 156081-01 |
| ID Number | NA |
| Device Expiration Date | 2002-01-31 |
| 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 | 336409 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | SANDHOFER STRASSE 116 MANNHEIM * D-68298 |
| Baseline Brand Name | C-REACTIVE PROTEIN (LATEX) |
| Baseline Generic Name | CLINICAL CHEMISTRY REAGENT |
| Baseline Model No | NA |
| Baseline Catalog No | 0764930 |
| Baseline ID | CRPLX |
| Baseline Device Family | INTEGRA FAMILY OF ANALYZERS |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 24 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K981897 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2001-08-02 |