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 2016-05-24 for ADVIA CHEMISTRY LIPASE REAGENTS 10311896 manufactured by Siemens Healthcare Diagnostics, Inc..
[45780488]
The cause of the high lipase result on the one patient sample is unknown. Siemens healthcare is investigating the issue.
Patient Sequence No: 1, Text Type: N, H10
[45780489]
The customer has obtained high results on one patient sample for lipase assay on the advia chemistry 1800 instrument when using reagent lot 364967. The sample was run three times on the same instrument and the values were high. The sample was repeated on an alternate platform and the value was lower. The sample was re-run on another day on the same advia chemistry instrument and the values obtained were still high. The customer has indicated that the patient was hospitalized due to the high result. The initial results were reported to the physician(s). It is unknown if the results from the alternate platform were reported. There were no reports of patient intervention or adverse health consequences due to the high result for lipase.
Patient Sequence No: 1, Text Type: D, B5
[55339710]
The initial mdr 2432235-2016-00285 was filed on 5/24/2016. Additional information (7/11/2016): the customer informed siemens healthcare that the contamination settings for the lipase assay was correct on the instrument. A siemens headquarters support specialist (hsc) reviewed the information provided by the customer. Based on the information provided the cause for the falsely high result could not be determined. Hsc provided troubleshooting steps to the customer to ensure that the system was performing per specifications. The customer has informed siemens that they are satisfied with the performance of the system. There have been no additional discordant patient results reported by the customer. The cause of the falsely high result for lipase is unknown. No further evaluation of the device is required. The system is performing according to specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2016-00285 |
| MDR Report Key | 5675823 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-05-24 |
| Date of Report | 2016-09-01 |
| Date of Event | 2016-04-26 |
| Date Mfgr Received | 2016-07-11 |
| Date Added to Maude | 2016-05-24 |
| 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 LABORATORES LTD. (REG# 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 | 2016-05-24 |
| Model Number | ADVIA CHEMISTRY LIPASE REAGENTS |
| Catalog Number | 10311896 |
| Lot Number | 364967 |
| Device Availability | * |
| 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 AVENUE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-24 |