MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2000-04-24 for TINA-QUANT CRP * 1299859 manufactured by Roche Diagnostics Corp..
[151702]
Investigations have shown suspect reagent in some cases, may initially produce falsely elevated results with certain specimens.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2000-00097 |
| MDR Report Key | 276088 |
| Report Source | 07 |
| Date Received | 2000-04-24 |
| Date of Event | 2000-04-14 |
| Date Added to Maude | 2000-05-04 |
| 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 | DEBRA REEK |
| Manufacturer Street | 9115 HAGUE ROAD |
| 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 | NO |
| Previous Use Code | 3 |
| Removal Correction Number | 1623260-4/20/00-0005-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TINA-QUANT CRP |
| Generic Name | CLINICAL CHEMISTRY REAGENT |
| Product Code | DCN |
| Date Received | 2000-04-24 |
| Model Number | * |
| Catalog Number | 1299859 |
| Lot Number | ALL |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 267226 |
| Manufacturer | ROCHE DIAGNOSTICS CORP. |
| Manufacturer Address | GMBH MANNHEIM GM D-68298 |
| Baseline Brand Name | TINA-QUANT CRP |
| Baseline Generic Name | CLINICAL CHEMISTRY REAGENT |
| Baseline Model No | NA |
| Baseline Catalog No | 1299859 |
| Baseline ID | NA |
| Baseline Device Family | CRP |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K871895 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2000-04-24 |