MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-07-13 for ACTH CHEMILUMINESCENCE IMMUNOASSAY KIT 60-4175 manufactured by Nichols Inst..
[19242523]
When correlating mfr's chemiluminesence immunoassay method for acth (x) against the irma immunoassay method for acth (y) rptr found a significant bias described by the equation y = 1. 279x + 6. 1. The mean result of 17 pt samples done by the irma method was 145. 8 pg/ml, the mean of the chemil method was 118. 7 pg/ml. The reference ranges reported by nichols for the two methods is almost identical. The irma range is 9-52 pg/ml and the chemiluminescence is 7-51 pg/ml. As established via phone calls, the mfr was aware of this bias and was in the process of restandardizing both methods and re-establishing the reference ranges. However, rptr was not notified of the bias which existed between the results of these 2 methods.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1006485 |
| MDR Report Key | 23447 |
| Date Received | 1995-07-13 |
| Date of Report | 1995-06-28 |
| Date of Event | 1995-06-16 |
| Date Added to Maude | 1995-07-13 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACTH CHEMILUMINESCENCE IMMUNOASSAY KIT |
| Generic Name | IMMUNOASSAY KIT |
| Product Code | CKG |
| Date Received | 1995-07-13 |
| Catalog Number | 60-4175 |
| Lot Number | 501914 |
| Device Expiration Date | 1996-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 23730 |
| Manufacturer | NICHOLS INST. |
| Manufacturer Address | SAN JUAN CAPISTRANO CA 92690 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1995-07-13 |