MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-05-10 for ADVIA CENTAUR CP CKMB ASSAY N/A 00481201 manufactured by Siemens Healthcare Diagnostics, Inc..
[3167029]
A falsely elevated advia centaur cp ckmb result was obtained on a patient sample and reported to the physician. The result was considered discordant when compared to dilution results, alternate test method results and the patient's clinical picture. There was no report of patient treatment being prescribed or altered and there was no report of adverse health consequences due to the discordant advia centaur cp ckmb result.
Patient Sequence No: 1, Text Type: D, B5
[10757768]
Siemens healthcare diagnostics received a patient sample from the customer. The returned patient sample was run neat, a 1:2 dilution and treated using a heterophilic blocking tube (hbt). The neat result was 57. 97 ng/ml, confirming the customer's elevated results. The diluted result was <0. 18 ng/ml and the hbt result of 0. 30 ng/ml indicating that the high neat result was most likely caused by interference of heterophilic antibodies in the sample. The information for use (ifu) in the limitations section states: "heterophilic antibodies in human serum can react with reagent immunoglobulins, interfering with in vitro immunoassays. "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219913-2013-00097 |
| MDR Report Key | 3107548 |
| Report Source | 05,06 |
| Date Received | 2013-05-10 |
| Date of Report | 2013-04-14 |
| Date of Event | 2013-04-14 |
| Date Mfgr Received | 2013-04-14 |
| Date Added to Maude | 2013-07-17 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. STEPHEN PERRY |
| Manufacturer Street | 333 CONEY STREET |
| Manufacturer City | EAST 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 | EAST WALPOLE MA 02032 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02032 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CENTAUR CP CKMB ASSAY |
| Generic Name | CKMB IMMUNOASSAY |
| Product Code | JHS |
| Date Received | 2013-05-10 |
| Model Number | N/A |
| Catalog Number | 00481201 |
| Lot Number | 014187 |
| ID Number | N/A |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | N |
| 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 | 2013-05-10 |