MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2002-02-21 for TINA QUANT IGM * 1929305 manufactured by Roche - Gmbh.
[19076464]
Precipitate in specific lots of clinical chemistry reagent can lead to falsely high or low results; when run on analyzer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2002-00061 |
| MDR Report Key | 378793 |
| Report Source | 05 |
| Date Received | 2002-02-21 |
| Date of Report | 2002-02-20 |
| Date of Event | 2002-01-30 |
| Date Mfgr Received | 2002-01-30 |
| Device Manufacturer Date | 2001-03-01 |
| Date Added to Maude | 2002-02-28 |
| 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 |
| Removal Correction Number | 1823260-02/08/02-001-R |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TINA QUANT IGM |
| Generic Name | CLINICAL CHEMISTRY REAGENT |
| Product Code | DAO |
| Date Received | 2002-02-21 |
| Model Number | * |
| Catalog Number | 1929305 |
| Lot Number | 62246301 |
| ID Number | * |
| Device Expiration Date | 2002-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE - GMBH |
| Manufacturer Address | SANDOFER STRASSE 116 MANNHEIM D-68298 * D-68298 |
| Baseline Brand Name | TINA QUANT IGM |
| Baseline Generic Name | IMMUNOASSAY |
| Baseline Model No | NA |
| Baseline Catalog No | 1929305 |
| Baseline ID | NA |
| Baseline Device Family | HITACHI FAMILY OF ANALYZERS |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | 22 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K955908 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2002-02-21 |