MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2016-10-19 for IMMULITE 2000 ACTH L2KAC2 manufactured by Siemens Healthcare Diagnostics Products, Limited.
[57925174]
A siemens headquarters support center (hsc) specialist reviewed the data provided by the customer. The hsc specialist indicated that acth assay measures intact acth by using antibodies directed against the c and n terminal peptide sequences. The cross-reactivity between the intermediate peptides is not expected. The cause of the discordant, falsely elevated acth results is unknown.
Patient Sequence No: 1, Text Type: N, H10
[57925175]
A discordant, falsely elevated adrenocorticotropic hormone (acth) result was obtained on one patient sample on an immulite 2000 xpi instrument, when using reagent kit 291. A new sample was obtained from the patient and was tested on an alternate site where it was run on another immulite 2000 instrument, also resulting elevated. The patient also had previous acth testing performed on an unknown platform on (b)(6) 2016 and both the results were elevated. The patient had undergone imagiology examination due to the discordant results and the imagiology examination results were normal. The discordant results were reported to the physician(s) and questioned due to the normal imagiology results. It is unknown if the corrected result was reported to the physician(s). There were no reports of adverse health consequences due to the discordant, falsely elevated acth results.
Patient Sequence No: 1, Text Type: D, B5
[58381002]
The initial mdr 2432235-2016-00636 was filed on october 19, 2016. Corrected information (10/20/2016): section of the initial mdr states that model # is immulite 2000 psa. The correct model # is immulite 2000 acth. Section has been updated with this information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2016-00636 |
| MDR Report Key | 6041815 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-10-19 |
| Date of Report | 2016-10-20 |
| Date of Event | 2016-07-22 |
| Date Mfgr Received | 2016-10-20 |
| Date Added to Maude | 2016-10-19 |
| 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 | 3 |
| Manufacturer Contact | AARTI AZIZ |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242683 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED |
| Manufacturer Street | REGISTRATION #: 3002806944 GLYN RHONWY |
| Manufacturer City | LLANBERIS, GWYNEDD, LL554EL |
| Manufacturer Country | UK |
| Manufacturer Postal Code | LL55 4EL |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMULITE 2000 ACTH |
| Generic Name | IMMULITE 2000 ACTH |
| Product Code | CKG |
| Date Received | 2016-10-19 |
| Model Number | IMMULITE 2000 ACTH |
| Catalog Number | L2KAC2 |
| Lot Number | 291 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED |
| Manufacturer Address | REGISTRATION #: 3002806944 GLYN RHONWY LLANBERIS, GWYNEDD, LL554EL UK LL55 4EL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-10-19 |