MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2001-09-05 for TINA-QUANT IGM 1929305 manufactured by Rd Gmbh.
[232760]
Igm assay gave a falsely low result, but gave a higher result when the sample was diluted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2001-00197 |
| MDR Report Key | 350559 |
| Report Source | 04 |
| Date Received | 2001-09-05 |
| Date of Report | 2001-08-30 |
| Date of Event | 2001-07-11 |
| Date Mfgr Received | 2001-07-11 |
| Device Manufacturer Date | 1999-09-01 |
| Date Added to Maude | 2001-09-12 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TINA-QUANT IGM |
| Generic Name | CLINICAL CHEMISTRY ASSAY |
| Product Code | DAO |
| Date Received | 2001-09-05 |
| Model Number | NA |
| Catalog Number | 1929305 |
| Lot Number | 60688801 |
| ID Number | NA |
| Device Expiration Date | 2001-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 339854 |
| Manufacturer | RD GMBH |
| Manufacturer Address | SANDOFER STRASSE 116 * * D-68305 |
| 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 | 2001-09-05 |