FDA Adverse Event
Injury
Summary report: N
NA INTACT PTH CHEMILUMINESCENSE KIT
MDR report key: 774238
·
Received October 24, 2006
Report
- Report Number
- 2050095-2006-00002
- Event Type
- Injury
- Date Received
- October 24, 2006
- Date of Event
- August 2, 2005
- Report Date
- September 1, 2005
- Manufacturer
- NICHOLS INSTITUTE DIAGNOSTICS
- Product Code
- CEW
- PMA / PMN Number
- k954418
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
PRODUCT LABELING STATES: "ASSAY RESULTS SHOULD BE USED IN CONJUNCTION WITH OTHER CLINICAL DATA TO ASSIST THE CLINICIAN IN MAKING INDIVIDUAL PATIENT MANAGEMENT DECISIONS." NID HAS CEASED INFORMATION OPERATIONS AND NO LONGER MARKETS THIS PRODUCT.
Description of Event or Problem · 1
PATIENT ALLEGED THAT SHE UNDERWENT UNNECESSARY SURGERY (PARATHYROIDECTOMY) FOLLOWING LABORATORY TESTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NA INTACT PTH CHEMILUMINESCENSE KIT | INTACT PARATHYROID HORMONE (PTH) | CEW | NICHOLS INSTITUTE DIAGNOSTICS | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Hospitalization |