MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-08-31 for ADVIA CENTAUR XP AFP ASSAY N/A 10309979 manufactured by Siemens Healthcare Diagnostics, Inc..
[118899091]
The siemens technical application specialist (tas) was on site and performed a precision study. The precision study failed. First precision mean was 5. 287 and %cv was 8. 03. Second precision mean was 6. 237 and %cv was 9. 62. The acceptable cv is 3. 6%. The tas reviewed the august 2018 quality control (qc). No bias was detected on qc. The customer service engineer (cse) was dispatched for a total service call. The cse replaced the probe wash guide, probe wash check, pinch tubing, performed sample calibration and r1 calibration. The cse performed a precision run with 5 replicates. The 30 ng/ml cv% was at 4. 6 (cv% limit 5. 2) and the 170 ng/ml cv% was at 2. 0 (cv% limit 4. 4). The customer re-calibrated afp and ran quality controls which were acceptable. The cause for the discordant afp results is unknown. It appears the issue was with one sample that reported out <2. 5, then 25. 9 and <2. 5 ng/ml. This is likely due to a preanalytical issue with the sample itself. The customer reported the sample was slightly icteric which may indicated sample quality issue. In review of actions taken it does appear the sample was repeated after a recalibration with a fresh pack and the value went from <2. 5 to 2. 7. The qc was biased low for the calibration in which the <2. 5 value was obtained. The customer service engineer did make some mechanical adjustments which may have attributed and has run precision. The assay and instrument is running acceptably. The instrument is performing within specifications. No further evaluation of the device is required. The ifu states in the interpretation of results section: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings. "
Patient Sequence No: 1, Text Type: N, H10
[118899092]
A false high advia centaur xp afp result was obtained for a patient sample upon repeat. The initial result was <2. 5. The customer repeats all less than 2. 5 results. The patient sample was repeated again and the result was negative the negative result was reported to the physician. A new patient sample was recceived and tested in triplicate. The results were negative. Patient treatment was not prescribed or altered. There was no report of adverse health consequences due to the discordant afp results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219913-2018-00214 |
| MDR Report Key | 7837188 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-08-31 |
| Date of Report | 2018-08-31 |
| Date of Event | 2018-08-06 |
| Date Mfgr Received | 2018-08-09 |
| Date Added to Maude | 2018-08-31 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. EIMAN SULIEMAN |
| Manufacturer Street | 333 CONEY STREET |
| Manufacturer City | E. WALPOLE MA 02032 |
| Manufacturer Country | US |
| Manufacturer Postal | 02032 |
| Manufacturer Phone | 5086604603 |
| 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 AFP ASSAY |
| Generic Name | AFP IMMUNOASSAY |
| Product Code | LOJ |
| Date Received | 2018-08-31 |
| Model Number | N/A |
| Catalog Number | 10309979 |
| Lot Number | 09370199 |
| Device Expiration Date | 2019-05-15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
| Manufacturer Address | 511 BENEDICT AVENUE TARRYTOWN NY 105915097 US 105915097 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-31 |