FDA Adverse Event
Malfunction
Summary report: N
ACTH, CHEMILUMINISCENCE KIT
MDR report key: 1357875
·
Received October 24, 2006
Report
- Report Number
- 2050095-2006-00004
- Event Type
- Malfunction
- Date Received
- October 24, 2006
- Date of Event
- February 1, 2002
- Report Date
- February 1, 2002
- Manufacturer
- NICHOLS INSTITUTE DIAGNOSTICS
- Product Code
- CKG
- PMA / PMN Number
- K926396
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
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."
Description of Event or Problem · 1
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACTH, CHEMILUMINISCENCE KIT | ACTH ANALYSIS PRODUCT | CKG | NICHOLS INSTITUTE DIAGNOSTICS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |