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 2017-10-11 for ADVIA 1800 manufactured by Siemens Healthcare Diagnostics Inc..
[90208581]
A siemens customer service engineer (cse) was dispatched to the customer site. After analyzing the instrument, the cse aligned the reaction cuvette washer (wud) and dilution cuvette washer (dwud) nozzles into the cuvettes. The cse then performed wud and dwud maintenance and aligned reagent probe 1 into the cuvettes. The cse also aligned the dilution mixer height and dilution probe into the cuvettes. As per advia 1800 gluh_c instructions for use "siemens recommends the use of commercially available quality control materials with at least 2 levels (low and high). A satisfactory level of performance is achieved when the analyte values obtained are within the acceptable control range for the system or within your range, as determined by an appropriate internal laboratory quality control scheme. The actual frequency of control in a laboratory is based on many factors, such as workflow, system experience, and government regulation. Each laboratory should evaluate the controls based on the frequency established by their laboratory guidelines. When the method is performed, analyze at least 2 levels of controls daily. " the precision on quality control has been on target for gluh_c since troubleshooting was performed. The cause of the gluh_c results being reported while quality control being out of range was due to the user error. The cause of the quality control being out of range is unknown. The instrument is performing within manufacturing specifications. No further evaluation of device is required.
Patient Sequence No: 1, Text Type: N, H10
[90208582]
The customer of an advia 1800 instrument stated that their concentrated glucose hexokinase_3 (gluh_c) quality control was flagged out of range. Quality control had been ranging from equal to or greater than 3sd (standard deviation). The operator ran patient samples while quality control was out of range and the results were reported to the physician(s). The customer has stopped running gluh_c on this instrument. The customer stated that there were approximately 3000 patient samples run while quality control was out of range. The customer contacted the physician(s) and advised that gluh_c results during the timeframe of (b)(6) 2017 may be incorrect. The customer stated that some physician(s) have already performed repeat testing and some patients were referred for follow up testing based on the high results, while some results were consistent with the clinical picture. The customer will not review the samples run during the timeframe of (b)(6) 2017. There are no reports of patient intervention or adverse health consequence due to gluh_c results being reported while quality control was out of range.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2017-00548 |
| MDR Report Key | 6941665 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-10-11 |
| Date of Report | 2017-11-06 |
| Date of Event | 2017-08-30 |
| Date Mfgr Received | 2017-10-18 |
| Date Added to Maude | 2017-10-11 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARL AEBIG |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243102 |
| Manufacturer G1 | JEOL LTD. (REGISTRATION # 3003637681) |
| Manufacturer Street | 3-1-2 MUSASHINO AKISHIMA |
| Manufacturer City | TOKYO, 196-8558 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 196-8558 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA 1800 |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | CFR |
| Date Received | 2017-10-11 |
| Model Number | ADVIA 1800 |
| 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 AVE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-11 |