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 2016-11-03 for ADVIA CENTAUR XP CA 125II ASSAY N/A 10310443 manufactured by Siemens Healthcare Diagnostics, Inc..
[59134722]
The cause for the false low advia centaur xp ca 125ii patient results when compared to an alternate ca 125 test method is unknown. The customer's quality control results were acceptable at the time of testing. Siemens is investigating the incident. The instruction for use (ifu) under the limitation section states the following: "note do not interpret levels of ca 125 as absolute evidence of the presence or the absence of malignant disease. Before treatment, patients with confirmed ovarian carcinoma frequently have levels of ca 125 within the range observed in healthy individuals. Elevated levels of ca 125 can be observed in patients with nonmalignant diseases. Measurements of ca 125 should always be used in conjunction with other diagnostic procedures, including information from the patient's clinical evaluation. The concentration of ca 125 in a given specimen determined with assays from different manufacturers can vary due to differences in assay methods, calibration, and reagent specificity. Ca 125 determined with different manufacturers' assays will vary depending on the method of standardization and antibody specificity. "
Patient Sequence No: 1, Text Type: N, H10
[59134723]
A false low advia centaur xp ca 125ii result was obtained on a patient sample and considered discordant compared to an alternate ca 125 higher test method result. The patient was redrawn and the advia centaur xp ca 125ii was lower compared to the alternate ca 125 test method. A corrected report was issued by the customer. There are no known reports that treatment was altered or prescribed or adverse health consequences due to the lower advia centaur xp ca 125ii result.
Patient Sequence No: 1, Text Type: D, B5
[63943302]
Siemens filed the initial mdr 1219913-2016-00201 on 11/03/2016 for false low advia centaur xp ca 125ii patient result. On 12/06/2016 - additional information: immunoassays are also subject to a number of interferences including those caused by endogenous antibodies. Interference can occur because of heterophile antibodies, anti-animal antibodies and auto antibodies. Patients exposed to animals or animal serum products can be prone to this interference and anomalous values may be observed. The interfering antibodies can give rise to a falsely high or less commonly a falsely low result. The erroneous result is recognized as being inconsistent with the patient's clinical picture. The laboratory procedures generally used to identify the presence of interfering antibody are serial dilutions to demonstrate a nonlinear response. Please note an interferent may not necessarily be due to an interfering antibody but may be due to other exogenous interferences such as drugs, nutritional supplements and/or herbal medicine in the blood. The instruction for use (ifu) under the interpretation of results section states the following: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings. " the instruction for use (ifu) under the warning section states the following: "the concentration of ca 125 in a given specimen, as determined by assays from different manufacturers, can vary due to differences in assay methods and reagent specificity. The results reported by the laboratory to the physician must include the identity of the assay for ca 125 used. Values obtained with different assay methods cannot be used interchangeably. If, in the course of monitoring a patient, the assay method used for determining serial levels of ca 125 is changed, the laboratory must perform additional testing to confirm baseline values. The advia centaur ca 125ii assay is based on the oc 125 and m11 antibodies available through agreement with (b)(4). Assays using antibodies other than oc 125 and m11 may give different results. " the instruction for use (ifu) under the limitation section states the following: "do not interpret levels of ca 125 as absolute evidence of the presence or the absence of malignant disease. Before treatment, patients with confirmed ovarian carcinoma frequently have levels of ca 125 within the range observed in healthy individuals. Elevated levels of ca 125 can be observed in patients with nonmalignant diseases. Measurements of ca 125 should always be used in conjunction with other diagnostic procedures, including information from the patient's clinical evaluation. The concentration of ca 125 in a given specimen determined with assays from different manufacturers can vary due to differences in assay methods, calibration, and reagent specificity. Ca 125 determined with different manufacturers' assays will vary depending on the method of standardization and antibody specificity. " "heterophilic antibodies in human serum can react with reagent immunoglobulins, interfering with in vitro immunoassays. Patients routinely exposed to animals or to animal serum products can be prone to this interference and anomalous values may be observed. Additional information may be required for diagnosis. " the instrument is performing within specifications. No further investigation is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219913-2016-00201 |
| MDR Report Key | 6076655 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-11-03 |
| Date of Report | 2016-12-27 |
| Date of Event | 2016-09-19 |
| Date Mfgr Received | 2016-12-06 |
| Device Manufacturer Date | 2016-01-14 |
| Date Added to Maude | 2016-11-03 |
| 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 | MR. STEPHEN PERRY |
| Manufacturer Street | 333 CONEY STREET |
| Manufacturer City | E. WALPOLE MA 02032 |
| Manufacturer Country | US |
| Manufacturer Postal | 02032 |
| Manufacturer Phone | 5086604163 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
| Manufacturer Street | 333 CONEY STREET |
| Manufacturer City | E. WALPOLE MA 02032 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02032 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CENTAUR XP CA 125II ASSAY |
| Generic Name | CA 125II IMMUNOASSAY |
| Product Code | LTK |
| Date Received | 2016-11-03 |
| Model Number | N/A |
| Catalog Number | 10310443 |
| Lot Number | 169 |
| Device Expiration Date | 2017-01-14 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
| Manufacturer Address | TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-03 |