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 2016-02-25 for ADVIA CENTAUR XP manufactured by Siemens Healthcare Diagnostics Inc..
[39089173]
The customer contacted the siemens customer care center (ccc). The customer stated that no doctors have questioned any results and there were no corrected reports. The customer handles reagents, patients, and quality controls according to manufacturer's recommendations. In addition, the reagent appeared homogenous and all maintenance was up to date. The customer provided ccc with calibration and quality control data, which indicated calibration was valid and results were within range. The customer ran master curve material, and values were with range. The customer then ran a correlation study on atg with a previous reagent lot, and verified that the current reagent lot was acceptable. The customer declined service. The cause of the discordant atg result is unknown. All other patient samples tested for atg resulted as expected. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[39089174]
A patient sample was drawn on (b)(6) 2016 and was frozen. The customer stated the sample appeared slightly hemolyzed but had no bubbles or clots. The sample was thawed out on (b)(6) 2016, mixed and run from the primary tube on an advia centaur xp instrument, and an elevated anti-thyroglobulin (atg) result, above the assay range, was obtained. The result was not reported to the physician(s). The sample was repeated from the primary tube and auto diluted 1:5 and manually diluted 1:2 on the same day, resulting as "over diluted". The sample was repeated undiluted on the same instrument, resulting lower. There was no sample left for testing, causing delay in reporting a result for the patient. The customer stated that there was harm to the patient due to the delay in reporting the result but did not have any further information on the harm, other than the patient requiring a redraw.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2016-00100 |
| MDR Report Key | 5462172 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-02-25 |
| Date of Report | 2016-02-02 |
| Date of Event | 2016-02-01 |
| Date Mfgr Received | 2016-02-02 |
| Device Manufacturer Date | 2010-09-13 |
| Date Added to Maude | 2016-02-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | MS. MARGARITA KARAN |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243105 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Street | CHAPEL LANE |
| Manufacturer City | SWORDS, CO., DUBLIN EL, |
| Manufacturer Country | SZ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CENTAUR XP |
| Generic Name | IMMUNOASSAY ANALYZER |
| Product Code | JNL |
| Date Received | 2016-02-25 |
| Model Number | ADVIA CENTAUR XP |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Address | 511 BENEDICT AVENUE TARRYTOWN NY 10591 US 10591 |
| Brand Name | ADVIA CENTAUR XP |
| Generic Name | IMMUNOASSAY ANALYZER |
| Product Code | JJE |
| Date Received | 2016-02-25 |
| Model Number | ADVIA CENTAUR XP |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Address | 511 BENEDICT AVENUE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-02-25 |