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 2017-10-13 for ADVIA 2400 manufactured by Siemens Healthcare Diagnostics Inc..
[90305977]
The customer contacted the siemens customer care center (ccc) to report the discordant glucose hexokinase_3 result. Quality control (qc) was within range. A siemens customer service engineer (cse) was dispatched to the customer site. The service was performed over multiple visits. The cse performed adjustment of aspiration probe. The cse observed reaction cuvette washers (wud) needed cleaning. The cse performed cleaning of wud probes. The cse replaced clot sensor. A siemens headquarters support center (hsc) reviewed the information provided and concluded the event is not due to a reagent lot or method issue. The data is consistent with instrument related issues with the potential cause being the clogging of wud probes. Improper washing of the reaction tray (rrv) cuvettes due to the clogged detergent and aspiration lines on the wud is consistent with imprecision issues. The cause of the discordant glucose hexokinase_3 result is unknown. The instrument is performing according to the specifications. No further evaluation of this device is required. Mdr 2432235-2017-00553 was filed for the same event. Mdr 2432235-2017-00554 was filed for the same event.
Patient Sequence No: 1, Text Type: N, H10
[90305978]
A discordant, falsely high glucose hexokinase_3 result was obtained on one patient sample on an advia 2400 instrument. The discordant result was not reported to the physician(s). The sample was repeated on the same instrument and on an alternate instrument, recovering lower. The repeat result was reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant glucose hexokinase_3 result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2017-00550 |
| MDR Report Key | 6948211 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-10-13 |
| Date of Report | 2017-11-16 |
| Date of Event | 2017-09-14 |
| Date Mfgr Received | 2017-10-23 |
| Date Added to Maude | 2017-10-13 |
| 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 | MARGARITA KARAN |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243105 |
| Manufacturer G1 | JEOL LTD |
| Manufacturer Street | 3-1-2 MUSASHINO AKISHIMA REGISTRATION#: 3003637681 |
| 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 2400 |
| Generic Name | ADVIA 2400 |
| Product Code | CFR |
| Date Received | 2017-10-13 |
| Model Number | ADVIA 2400 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2017-10-13 |