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 2016-05-27 for ADVIA CHEMISTRY LIPASE REAGENTS manufactured by Siemens Healthcare Diagnostics Inc..
[46069618]
Siemens healthcare diagnostics has identified the potential for high biased advia? Chemistry systems lipase assay results due to carryover from one or more of the following tests: triglycerides, triglycerides _2, triglycerides concentrated, cholesterol concentrated, and direct ldl reagents. The root cause of this issue was determined to be inadequate contamination avoidance settings between lipase and lipid panel assays (triglycerides, chol_c and dldl). An urgent medical device correction (umdc) 11220133, rev. A was sent to us customers and an urgent field safety notice (ufsn) 11220075, rev. A was sent to ous customers in march of 2015. The umdc and ufsn state that customers are advised to continue using the advia chemistry lipase reagents and follow the rerun instructions in the customer letter if a high outlier is observed. The customer contacted a siemens customer care center (ccc) specialist. The customer stated that the discordant result was obtained when they ran the patient sample as a part of test panel, while the repeat results were obtained when lipase was run in standalone mode. A siemens headquarters support center (hsc) specialist reviewed the instrument data and determined that the customer did not configure the settings as per the customer bulletin 10813375 revision e. The cause of the discordant, falsely elevated lipase result on one patient sample is unknown. Siemens healthcare diagnostics is investigating the issue.
Patient Sequence No: 1, Text Type: N, H10
[46069619]
A discordant, falsely elevated lipase result was obtained on one patient sample on an advia chemistry 1800 instrument while using reagent lot 364967. The discordant result was reported to the physician(s). A different sample was obtained from the patient and was tested twice on the same instrument, resulting lower both times. The sample was also repeated on an alternate advia chemistry 1800 instrument. The customer did not provide the result obtained on the alternate advia chemistry 1800 instrument. The corrected results were reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant, falsely elevated lipase result.
Patient Sequence No: 1, Text Type: D, B5
[47911312]
The initial mdr 2432235-2016-00262 was filed on may 27, 2016. Additional information (06/01/2016): a siemens technical application specialist (tas) revised and corrected the contamination settings. The cause of the discordant, falsely elevated lipase result on one patient sample is unknown.
Patient Sequence No: 1, Text Type: N, H10
[50322800]
The initial mdr 2432235-2016-00262 was filed on may 27, 2016. The first supplemental mdr 2432235-2016-00262_s1 was filed on june 22, 2016. Additional information (06/21/2016): upon a siemens headquarters support center (hsc) specialist's recommendation, a siemens technical application specialist revised and corrected the contamination settings. A siemens customer service engineer was dispatched to the customer site and checked all the alignments on the instrument. The cse monitored the routine run of assays and the patient samples were repeated, which were acceptable.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2016-00262 |
| MDR Report Key | 5684429 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-05-27 |
| Date of Report | 2016-07-08 |
| Date of Event | 2016-05-05 |
| Date Mfgr Received | 2016-06-21 |
| Date Added to Maude | 2016-05-27 |
| 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 |
| Removal Correction Number | 2432235-03/24/2015-002-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CHEMISTRY LIPASE REAGENTS |
| Generic Name | ADVIA CHEMISTRY LIPASE REAGENTS |
| Product Code | CHI |
| Date Received | 2016-05-27 |
| Model Number | ADVIA CHEMISTRY LIPASE REAGENTS |
| Lot Number | 364967 |
| 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 | 2016-05-27 |