MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-10-24 for ACTH, CHEMILUMINISCENCE KIT 60-4175 manufactured by Nichols Institute Diagnostics.
[1069697]
The clinic reported that 6 patients received dex treatment to suppress acth values following laboratory test results showing high acth values inb these patients. Subsequent irma acth tests on the same samples from the patients showed normal acth values.
Patient Sequence No: 1, Text Type: D, B5
[8224057]
This report is based on info found during a review of nid files. Nid has ceased manufacturing operations and no longer markets this product. The product labeling states: "like any analyte used as a diagnostic adjunct, acth results must be interpreted carefully with the overall clinical presentations and other supportive diagnostic tests. "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050095-2006-00004 |
| MDR Report Key | 1357875 |
| Report Source | 05 |
| Date Received | 2006-10-24 |
| Date of Report | 2002-02-01 |
| Date of Event | 2002-02-01 |
| Date Mfgr Received | 2002-02-01 |
| Date Added to Maude | 2009-10-14 |
| 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 |
| 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 | 9499409465 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACTH, CHEMILUMINISCENCE KIT |
| Generic Name | ACTH ANALYSIS PRODUCT |
| Product Code | CKG |
| Date Received | 2006-10-24 |
| Catalog Number | 60-4175 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NICHOLS INSTITUTE DIAGNOSTICS |
| Manufacturer Address | 1311 CALLE BATIDO SAN CLEMENTE CA 92673 US 92673 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-10-24 |