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 2017-03-24 for ADVIA CHEMISTRY LIPASE REAGENTS 10311896 manufactured by Siemens Healthcare Diagnostics Inc..
[70796083]
Siemens is investigating the issue. The cause of the discordant, falsely elevated lipase result on one patient sample is unknown.
Patient Sequence No: 1, Text Type: N, H10
[70796084]
The customer obtained discordant, falsely elevated lipase result on one patient sample on an advia chemistry xpt instrument, while using reagent kit lot 401119. The customer has a setting on the instrument to auto repeat the results greater than 35 u/l. The first repeat run was auto repeat and the second repeat run was performed manually, both resulting lower. The discordant result was not reported to the physician(s). The repeat results were reported to the physician(s). There are no reports of patient intervention or adverse health consequence due to the discordant, falsely elevated result.
Patient Sequence No: 1, Text Type: D, B5
[75234825]
The initial mdr 2432235-2017-00210 was filed on march 24, 2017. Additional information (04/07/2017): a siemens headquarters support center (hsc) specialist reviewed the information provided by the customer. There were no reports of quality control issues or issues with other patient samples. The hsc specialist stated that the advia chemistry xpt contamination avoidance settings are found in the customer bulletin 10815606, rev. E, issued 2017-02. The hsc specialist recommended that the customer ensures the contamination avoidance settings provided within this document matches what is in the instrument and that the process order is configured correctly. The cause of the discordant, falsely elevated lipase result on one patient sample is unknown. The instrument is performing as expected. No further evaluation of device is required.
Patient Sequence No: 1, Text Type: N, H10
[86926918]
The initial mdr 2432235-2017-00210 was filed on march 24, 2017. The first supplemental mdr 2432235-2017-00210_s1 was filed on may 4, 2017. Additional information (05/24/2017): a siemens customer care center specialist followed the siemens headquarters support center specialist's recommendations and verified that the advia chemistry xpt contamination avoidance settings at the customer site were in accordance with the customer bulletin 10815606, rev. E, issued 2017-02.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2017-00210 |
| MDR Report Key | 6431699 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-03-24 |
| Date of Report | 2017-06-13 |
| Date of Event | 2017-02-27 |
| Date Mfgr Received | 2017-05-24 |
| Date Added to Maude | 2017-03-24 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | AARTI AZIZ |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242683 |
| Manufacturer G1 | RANDOX LABORATORIES LTD. (REGISTRATION # 8020890) |
| Manufacturer Street | 55 DIAMOND ROAD CRUMLIN |
| Manufacturer City | CO. ANTRIM, BT294QY |
| Manufacturer Country | UK |
| Manufacturer Postal Code | BT29 4QY |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CHEMISTRY LIPASE REAGENTS |
| Generic Name | ADVIA CHEMISTRY LIPASE REAGENTS |
| Product Code | CHI |
| Date Received | 2017-03-24 |
| Model Number | ADVIA CHEMISTRY LIPASE REAGENTS |
| Catalog Number | 10311896 |
| Lot Number | 401119 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| 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 | 2017-03-24 |