MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2006-10-24 for CALCITONIN CHEMILUMINESCENCE KIT * 60-4410 manufactured by Nichols Institute Diagnostics.
[17870152]
A patient in another country claimed that she underwent unnecessary surgery following a false positive result obtained by laboratory tests utilizing this assay.
Patient Sequence No: 1, Text Type: D, B5
[18014142]
This information was found during a review of nid files. Nid has ceased manufacturing operations and no longer markets this product. The product labeling states: "for diagnostic purposes, values obtained with the nichols advantage calcitonin should be used as an adjunct to other data available to the physician. "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050095-2006-00005 |
| MDR Report Key | 774398 |
| Report Source | 00 |
| Date Received | 2006-10-24 |
| Date of Report | 2003-10-01 |
| Date of Event | 2001-10-01 |
| Date Mfgr Received | 2006-10-01 |
| Date Added to Maude | 2006-10-31 |
| 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 | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | ANIL BHALANI, DIRECTOR |
| Manufacturer Street | 1311 CALLE BATIDO |
| Manufacturer City | SAN CLEMENTE CA 92673 |
| Manufacturer Country | US |
| Manufacturer Postal | 92673 |
| Manufacturer Phone | 9499407465 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CALCITONIN CHEMILUMINESCENCE KIT |
| Generic Name | CALCITONIN IMMUNOASSAY |
| Product Code | JKR |
| Date Received | 2006-10-24 |
| Model Number | * |
| Catalog Number | 60-4410 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 762179 |
| Manufacturer | NICHOLS INSTITUTE DIAGNOSTICS |
| Manufacturer Address | 1311 CALLE BATIDO SAN CLEMENTE CA 92673 US |
| Baseline Brand Name | CALCITONIN CHEMILUMINESCENCE KIT |
| Baseline Generic Name | CALCITONIN IMMUNOASSAY |
| Baseline Model No | * |
| Baseline Catalog No | 60-4410 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2006-10-24 |