MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2001-05-29 for CALCIUM * 3033406 manufactured by Raichem.
[191112]
Clinical chemistry reagent gave elevated results with patient sample. Doctor sent patient to hospital for redraw; the retest was within range, no action based on the results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2001-00107 |
| MDR Report Key | 335380 |
| Report Source | 05 |
| Date Received | 2001-05-29 |
| Date of Report | 2001-05-24 |
| Date of Event | 2001-05-14 |
| Date Mfgr Received | 2001-05-14 |
| Date Added to Maude | 2001-06-04 |
| 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 | 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 | CALCIUM |
| Generic Name | CLINICAL CHEMISTRY REAGENT |
| Product Code | JFP |
| Date Received | 2001-05-29 |
| Model Number | * |
| Catalog Number | 3033406 |
| Lot Number | B9442 |
| ID Number | * |
| Device Expiration Date | 2003-06-01 |
| 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 | 324727 |
| Manufacturer | RAICHEM |
| Manufacturer Address | 8225 MERCURY COURT SAN DIEGO CA 92111 US |
| Baseline Brand Name | CALCIUM |
| Baseline Generic Name | CLINICAL CHEMISTRY REAGENT |
| Baseline Model No | * |
| Baseline Catalog No | 3033406 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2001-05-29 |